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Use of UC-MSCs for COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355728
Recruitment Status : Completed
First Posted : April 21, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Camillo Ricordi, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Corona Virus Infection
ARDS
ARDS, Human
Acute Respiratory Distress Syndrome
COVID-19
Interventions Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.
Other: Vehicle + Heparin along with best supportive care
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title UC-MSCs Group Control Group Total
Hide Arm/Group Description

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  66.7%
7
  58.3%
15
  62.5%
>=65 years
4
  33.3%
5
  41.7%
9
  37.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
58.58  (15.93) 58.83  (11.61) 58.71  (13.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
7
  58.3%
4
  33.3%
11
  45.8%
Male
5
  41.7%
8
  66.7%
13
  54.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hispanic or Latino
11
  91.7%
11
  91.7%
22
  91.7%
Not Hispanic or Latino
1
   8.3%
1
   8.3%
2
   8.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   8.3%
2
  16.7%
3
  12.5%
White
11
  91.7%
10
  83.3%
21
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
Hemogoblin from Complete Blood Count  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 12 participants 12 participants 24 participants
12.93  (2.04) 12.45  (2.35) 12.69  (2.17)
Hematocrit from Complete Blood Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total blood volume
Number Analyzed 11 participants 9 participants 20 participants
39.71  (6.53) 40.76  (5.08) 40.18  (5.79)
[1]
Measure Analysis Population Description: Data missing. CBC with differential at baseline was not done in a subset of patients.
White Blood Count (WBC) from Complete Blood Count  
Mean (Standard Deviation)
Unit of measure:  10^3 cells/uL
Number Analyzed 12 participants 12 participants 24 participants
11.87  (5.26) 14.17  (5.45) 13.02  (5.37)
Neutrophils from Complete Blood Count   [1] 
Mean (Standard Deviation)
Unit of measure:  10^3 cells/uL
Number Analyzed 11 participants 10 participants 21 participants
9.25  (4.8) 13.37  (5.33) 11.21  (5.36)
[1]
Measure Analysis Population Description: Data missing. CBC with differential at baseline was not done in a subset of patients.
Lymphocytes from Complete Blood Count   [1] 
Mean (Standard Deviation)
Unit of measure:  10^3 cells/uL
Number Analyzed 11 participants 10 participants 21 participants
1.15  (0.79) 0.72  (0.25) 0.95  (0.62)
[1]
Measure Analysis Population Description: Data missing. CBC with differential at baseline was not done in a subset of patients.
Platelet count from Complete Blood Count  
Mean (Standard Deviation)
Unit of measure:  10^3 cells/uL
Number Analyzed 12 participants 12 participants 24 participants
329.83  (99.52) 342.58  (91.83) 336.21  (93.88)
Glomerular Filtration Rate from Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m^2
Number Analyzed 12 participants 12 participants 24 participants
74.5  (31.61) 61.25  (37.59) 67.88  (34.63)
Total Protein from Comprehensive Metabolic Panel   [1] 
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 10 participants 10 participants 20 participants
6.39  (0.69) 6.45  (0.68) 6.42  (0.67)
[1]
Measure Analysis Population Description: Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Sodium for Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 12 participants 12 participants 24 participants
138.92  (3.15) 136.58  (5.04) 137.75  (4.28)
Potassium for Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 12 participants 12 participants 24 participants
4.37  (0.55) 4.52  (0.67) 4.44  (0.6)
Creatine for Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 24 participants
1.18  (0.77) 1.92  (1.88) 1.55  (1.46)
Glucose for Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 24 participants
190.75  (107.14) 193.67  (85.44) 192.21  (94.78)
Albumin for Comprehensive Metabolic Panel   [1] 
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 10 participants 10 participants 20 participants
3.22  (0.39) 3.21  (0.51) 3.22  (0.44)
[1]
Measure Analysis Population Description: Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Alkaline Phosphatase for Comprehensive Metabolic Panel   [1] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 10 participants 10 participants 20 participants
90.9  (59.3) 96.5  (52.69) 93.7  (54.67)
[1]
Measure Analysis Population Description: Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Alanine Aminotransferase (ALT) or Serum Glutamic-pyruvic Transaminase (SGPT)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 10 participants 11 participants 21 participants
72.1  (51.19) 82.45  (75.18) 77.52  (63.51)
[1]
Measure Description: Alanine Aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT) for comprehensive metabolic panel as assessed from serum blood samples.
[2]
Measure Analysis Population Description: Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 10 participants 11 participants 21 participants
55.8  (31.07) 118.45  (153.16) 88.62  (114.86)
[1]
Measure Description: Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT) for the comprehensive metabolic panel assessed from serum blood samples.
[2]
Measure Analysis Population Description: Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Total Bilirubin for Comprehensive Metabolic Panel   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 10 participants 20 participants
0.62  (0.39) 0.65  (0.25) 0.64  (0.32)
[1]
Measure Analysis Population Description: Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.
Blood Urea Nitrogen (BUN) for Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 24 participants
29.58  (16.61) 42.67  (31.27) 36.13  (25.38)
Calcium for Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 12 participants 12 participants 24 participants
8.53  (0.4) 8.32  (0.87) 8.43  (0.67)
Chloride Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 12 participants 12 participants 24 participants
101  (4.29) 100.5  (6.33) 100.75  (5.29)
Carbon Dioxide (CO2) for Comprehensive Metabolic Panel  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 12 participants 12 participants 24 participants
24.42  (3.99) 21.92  (4.62) 23.17  (4.41)
Oxygenation Index   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Index
Number Analyzed 4 participants 6 participants 10 participants
8.09  (2.63) 14.32  (14.68) 11.83  (11.5)
[1]
Measure Description: Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen).
[2]
Measure Analysis Population Description: Data missing. Oxidation Index is only measured and calculated in ventilated patients.
Positive End-Expiratory Pressure (PEEP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm H2O
Number Analyzed 4 participants 7 participants 11 participants
13.75  (2.06) 12.71  (2.14) 13.09  (2.07)
[1]
Measure Analysis Population Description: Data missing. PEEP is only measured in patients on ventilator.
Plateau Pressure   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Cm H2O
Number Analyzed 4 participants 4 participants 8 participants
13.75  (9.74) 29  (7.39) 21.38  (11.43)
[1]
Measure Description: Plateau pressure as assessed for patients on a ventilator
[2]
Measure Analysis Population Description: Data missing. Plateau Pressure is only measured in patients on ventilator.
Sequential Organ Failure Assessment (SOFA) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 12 participants 11 participants 23 participants
5.5  (2.61) 7.64  (3.35) 6.52  (3.12)
[1]
Measure Description: Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). Totaling a maximum SOFA score of 24 and minimum of 0.
[2]
Measure Analysis Population Description: Data missing.
C-Reactive Protein (CRP)  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 12 participants 12 participants 24 participants
97.97  (77.56) 144.35  (115.69) 121.16  (99.19)
D-Dimer   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mcg/mL FEU
Number Analyzed 12 participants 11 participants 23 participants
1.76  (2.35) 4.96  (6.04) 3.29  (4.69)
[1]
Measure Description: D-dimer as assessed from serum blood samples.
[2]
Measure Analysis Population Description: data missing. Collected in a tube that has been recalled by the manufacturer so test was canceled by Quest
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio of AA to EPA
Number Analyzed 12 participants 12 participants 24 participants
45.38  (24.89) 45.79  (23.93) 45.58  (23.88)
[1]
Measure Description: ratio of AA to EPA as assessed via serum blood samples.
25-OH vitamin D levels  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 12 participants 12 participants 24 participants
21.76  (8.48) 23.19  (12.85) 22.47  (10.68)
Respiratory Rate and Oxygenation Index (ROX)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Index
Number Analyzed 8 participants 5 participants 13 participants
7.36  (7.73) 3.59  (1.13) 5.91  (6.24)
[1]
Measure Description: The ROX index is the measure of the ratio of pulse oximetry/fraction of inspired oxygen (SpO2/FiO2) to respiratory rate (RR). The ROX index is used as a predictor of the need to intubate in patients receiving HFNC oxygen therapy; performed at 2, 6 and 12 hours. ROX at 2, 6 and 12 hours after HFNC initiation was associated with a lower risk for intubation. For a ROX Index <3.85, risk of HFNC failure is high. If ROX Index 3.85 to <4.88, the scoring could be repeated one or two hours later for further evaluation.
[2]
Measure Analysis Population Description: data missing. Some patients were on a ventilator. Patients only on HFNC have ROX scores.
Viral Load by SARS-CoV-2 RT-PCR   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Copies
Number Analyzed 12 participants 12 participants 24 participants
352
(47 to 2184.5)
3570.50
(175 to 18408.50)
710
(114 to 10799.50)
[1]
Measure Description: Viral load as assessed in blood plasma for SARS-CoV-2
Panel Reactive Antibody (PRA)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
PRA Results Class I Number Analyzed 12 participants 12 participants 24 participants
Positive PRA
11
  91.7%
9
  75.0%
20
  83.3%
Negative PRA
1
   8.3%
3
  25.0%
4
  16.7%
PRA Results Class II Number Analyzed 12 participants 12 participants 24 participants
Positive PRA
4
  33.3%
6
  50.0%
10
  41.7%
Negative PRA
8
  66.7%
6
  50.0%
14
  58.3%
[1]
Measure Description: Panel Reactive Antibody (PRA) for Class I and Class II assessed via serum blood samples
Serology (anti-SARS-CoV-2 IgM and IgG)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
IgM Number Analyzed 10 participants 9 participants 19 participants
Positive
4
  40.0%
5
  55.6%
9
  47.4%
Negative
6
  60.0%
2
  22.2%
8
  42.1%
Borderline
0
   0.0%
2
  22.2%
2
  10.5%
IgG Number Analyzed 10 participants 9 participants 19 participants
Positive
5
  50.0%
8
  88.9%
13
  68.4%
Negative
4
  40.0%
1
  11.1%
5
  26.3%
Borderline
1
  10.0%
0
   0.0%
1
   5.3%
[1]
Measure Description: Serology (anti-SARS-CoV-2 IgM and IgG) analyzed in blood serum samples.
[2]
Measure Analysis Population Description: These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.
1.Primary Outcome
Title Number of Participants With Pre-Specified Infusion Associated Adverse Events
Hide Description

Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:

  1. An increase in vasopressor dose greater than or equal to the following:

    • Norepinephrine: 10 μg/min
    • Phenylephrine: 100 μg/min
    • Dopamine: 10 μg/kg/min
    • Epinephrine: 10 μg/min
  2. In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of >20%.
  3. In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation.
  4. New cardiac arrhythmia requiring cardioversion
  5. New ventricular tachycardia, ventricular fibrillation, or asystole
  6. A clinical scenario consistent with transfusion incompatibility or transfusion-related infection
  7. Cardiac arrest or death within 24h post infusion
Time Frame 6 and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC treatment group, 4 participants were on mechanical ventilation and 8 participants were receiving high flow oxygen therapy. In the control group 7 participants were on mechanical ventilation and 5 participants were receiving high flow oxygen therapy.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Number of subjects with an increase in vasopressor dose at 6 h Number Analyzed 12 participants 12 participants
1
   8.3%
1
   8.3%
In subjects receiving mechanical ventilation, Number of subjects with worsening of hypoxemia at 6 h Number Analyzed 4 participants 7 participants
1
  25.0%
1
  14.3%
In subjects on high flow oxygen therapy:worsening hypoxemia(req intubat, mechanical ventilat) at 6 h Number Analyzed 8 participants 5 participants
0
   0.0%
0
   0.0%
Number of subjects with new cardiac arrhythmia requiring cardioversion at 6 h Number Analyzed 12 participants 12 participants
0
   0.0%
1
   8.3%
Number of subjects with new ventricular tachycardia, ventricular fibrillation, or asystole at 6 h Number Analyzed 12 participants 12 participants
0
   0.0%
1
   8.3%
A clinical scenario consistent with transfusion incompatibility or transfusion-rel infection at 6h Number Analyzed 12 participants 12 participants
0
   0.0%
0
   0.0%
Number of subjects with cardiac arrest or death within 24 h post infusion Number Analyzed 12 participants 12 participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Serious Adverse Events by 31 Days After First Infusion
Hide Description The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion).
Time Frame 31 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  16.7%
8
  66.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments The null hypothesis is the following: "There is no difference in the number of subjects experiencing serious adverse events in the UC-MSC vs control group".
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90
Hide Description Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: percentage of participants
41.67 66.67
4.Primary Outcome
Title Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Total number of adverse events and serious adverse events as assessed by treating physician
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: Adverse Events
Number of Adverse Events (not including SAEs) 40 37
Number of Serious Adverse Events 6 16
5.Primary Outcome
Title Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Hide Description Total number of adverse events plus serious adverse events categorized by severity.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: Adverse Events
Mild 15 13
Moderate 22 21
Severe 9 19
6.Primary Outcome
Title Subjects With Adverse Events and Serious Adverse Events by Severity
Hide Description Total number of subjects with adverse events and serious adverse events categorized by severity.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who experience one or more AEs or SAEs within each category are counted only once.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
7
  58.3%
5
  41.7%
Moderate
7
  58.3%
8
  66.7%
Severe
5
  41.7%
7
  58.3%
7.Primary Outcome
Title Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment
Hide Description Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: Adverse Events
Unrelated 42 45
Unlikely 3 7
Possible 1 1
Probably 0 0
Definite 0 0
8.Primary Outcome
Title Subjects With Adverse Events by Relatedness to Treatment
Hide Description Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Unrelated
8
  66.7%
10
  83.3%
Unlikely
1
   8.3%
4
  33.3%
Possible
1
   8.3%
1
   8.3%
Probable
0
   0.0%
0
   0.0%
Defininte
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Survival at 31 Days Post First Infusion
Hide Description Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion.
Time Frame 31 Days
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the UC-MSC Group was not included in the data analysis due to failed intubation.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 11 12
Measure Type: Count of Participants
Unit of Measure: Participants
10
  90.9%
5
  41.7%
10.Secondary Outcome
Title Survival at 60 Days Post First Infusion
Hide Description Number of participants alive at 60 days post first infusion follow up.
Time Frame 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
A subject was censored due to failed intubation in the UC-MSC group.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 11 12
Measure Type: Count of Participants
Unit of Measure: Participants
9
  81.8%
5
  41.7%
11.Secondary Outcome
Title Time to Recovery
Hide Description Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered.
Time Frame 31 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: days
Days by which 75% of subjects were recovered
23 [1] 
(13.00 to NA)
NA [2] 
(NA to NA)
Days by which 50% of subjects were recovered
15
(6 to 23)
NA [2] 
(10 to NA)
Days by which 25% of subjects were recovered
8
(3 to 15)
12 [1] 
(9 to NA)
[1]
insufficient number of people recovered within 31 day limit to estimate the upper confidence
[2]
insufficient number of people recovered within 31 day limit
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments The null hypothesis is the following: "There is no difference in Time to Recovery up to 31 days post infusion between the UC-MSC group and control group". Time to recovery was estimated in each group with Kaplan-Meier survival estimates. Log-rank tests were used to compare hazards between groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0307
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.289
Confidence Interval (2-Sided) 95%
0.088 to 0.948
Estimation Comments Censoring was limited to dropout from study, and the event of interest was recovery. In the case of death, the patient's time to recovery was censored at the end of study observation; thus the patient remained in the risk set for all KM estimations.
12.Secondary Outcome
Title Ventilator-Free Days Throughout 28 Days Post Second Infusion
Hide Description Number of days participants were off ventilators during 28 days post second infusion.
Time Frame 28 days post second infusion
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC treatment group one subject was not included in the analysis due to censoring and another subject was not included due to loss to follow-up. In the control group one subject was not included in the analysis due to discharge against medical advice.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 10 11
Median (Inter-Quartile Range)
Unit of Measure: days
28
(24 to 28)
0
(0 to 28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0563
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Ventilator-Free Days Throughout 90 Days
Hide Description Number of days participants were off ventilators within up to 90 days of hospitalization.
Time Frame 90 days or hospital discharge, whichever is earlier
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC treatment group one subject was not included in the analysis due to censoring and another subject was not included due to loss to follow-up. In the control group one subject was not included in the analysis due to discharge against medical advice.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 10 11
Median (Inter-Quartile Range)
Unit of Measure: days
90
(86 to 90)
0
(0 to 90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0563
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Respiratory Rate and Oxygenation Index (ROX Index)
Hide Description Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
ROX index was only measured for patients receiving HFNC and/or not intubated patients. Three patients were ventilated in the UC-MSC group, one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, two patients data was not collected. In the control group one subject was not included in the analysis due to death before day 6, three patients were ventilated, and one patient data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 5 7
Mean (Standard Deviation)
Unit of Measure: Index
9.57  (5.23) 7.44  (2.9)
15.Secondary Outcome
Title Oxygenation Index (OI)
Hide Description Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen).
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
Oxidation Index is only measured and calculated in ventilated patients, therefore 3 patients in the UC-MSC group were included and 3 patients in the control group were included.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: Index
9.62  (1.43) 12.74  (5.21)
16.Secondary Outcome
Title Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)
Hide Description Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6)
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
PEEP and Plateau pressure are only measured in ventilated patients, therefore 3 patients in the UC-MSC group were included and 3 patients in the control group were included.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: cm H2O
PEEP Number Analyzed 3 participants 3 participants
9.73  (3.72) 11.67  (1.53)
Plateau Pressure Number Analyzed 3 participants 2 participants
28.67  (9.61) 24  (2.83)
17.Secondary Outcome
Title Sequential Organ Failure Assessment (SOFA) Scores
Hide Description Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure).
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC treatment group one subject was not included in the analysis due to death and 2 subjects were not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.56  (2.7) 6.82  (2.36)
18.Secondary Outcome
Title Smell Identification Test (SIT) Scores
Hide Description SIT measures the participant's sense of smell. SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
No participants in the study were able to complete the Smell Evaluation Test due to extenuating circumstances related to the COVID-19 pandemic.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title White Blood Cell Count (WBC)
Hide Description As assessed via serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/uL
13.43  (4.62) 15.53  (5.6)
20.Secondary Outcome
Title Platelets Count
Hide Description As assessed via serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/uL
342  (136.33) 397.89  (135.59)
21.Secondary Outcome
Title Hemogoblin
Hide Description Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: g/dL
11.93  (2.82) 11.94  (3.34)
22.Secondary Outcome
Title Hematocrit
Hide Description The percentage by volume of red cells in your blood as assessed via serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: percentage of red blood cells by volume
37.98  (8.32) 36.73  (9.56)
23.Secondary Outcome
Title Neutrophils
Hide Description the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and two subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/uL
9.74  (4.27) 13.4  (5.95)
24.Secondary Outcome
Title Lymphocytes
Hide Description Lymphocyte count as assessed via serum blood samples
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and two subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/uL
1.38  (1.07) 0.8  (0.41)
25.Secondary Outcome
Title Glomerular Filtration Rate
Hide Description Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 m^2
60.59  (26.99) 68.67  (35.4)
26.Secondary Outcome
Title Total Protein
Hide Description Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins.
Time Frame Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: g/dL
5.88  (0.54) 5.8  (1.06)
27.Secondary Outcome
Title Sodium
Hide Description Sodium levels as assessed by serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mmol/L
141.22  (6.24) 141  (9.57)
28.Secondary Outcome
Title Potassium
Hide Description Potassium levels as assessed via serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mmol/L
4.25  (0.71) 4.37  (0.73)
29.Secondary Outcome
Title Creatinine
Hide Description Creatinine levels as assessed via serum blood samples
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.21  (0.54) 1.24  (0.74)
30.Secondary Outcome
Title Glucose
Hide Description Glucose levels as assessed via serum blood samples
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
153.11  (63.99) 183.89  (82.33)
31.Secondary Outcome
Title Albumin
Hide Description Albumin levels as assessed via serum blood samples
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: g/dL
2.96  (0.43) 2.73  (0.45)
32.Secondary Outcome
Title Alkaline Phosphatase
Hide Description Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: U/L
136.2  (68.36) 202.5  (219.13)
33.Secondary Outcome
Title Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)
Hide Description The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: U/L
64.4  (38.43) 65.67  (45.04)
34.Secondary Outcome
Title Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)
Hide Description The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: U/L
55.8  (23.86) 47  (32.47)
35.Secondary Outcome
Title Total Bilirubin
Hide Description Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.88  (0.46) 0.77  (0.29)
36.Secondary Outcome
Title Blood Urea Nitrogen (BUN)
Hide Description Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
48  (22.28) 47.67  (26.97)
37.Secondary Outcome
Title Calcium
Hide Description Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
8.5  (0.58) 8.27  (0.67)
38.Secondary Outcome
Title Chloride
Hide Description Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mmol/L
101.56  (7.63) 102.44  (9.04)
39.Secondary Outcome
Title Carbon Dioxide (CO2)
Hide Description Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 9
Mean (Standard Deviation)
Unit of Measure: mmol/L
28.44  (3.75) 26.44  (4.61)
40.Secondary Outcome
Title C-Reactive Protein Levels
Hide Description As assessed via serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and data was missing for two subjects. In the control group one subject was not included in the analysis due to death before day 6.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 8 11
Mean (Standard Deviation)
Unit of Measure: mg/L
101.01  (131.05) 112.55  (104.7)
41.Secondary Outcome
Title Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio
Hide Description As assessed via serum blood samples on day 6 (visit 8).
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: ratio of AA to EPA
33.6  (12) 34.64  (13.24)
42.Secondary Outcome
Title D-dimer Levels
Hide Description As assessed via serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6 and one subject data was not collected.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: mcg/ml FEU
6.2  (11.29) 4.69  (3.38)
43.Secondary Outcome
Title 25-Hydroxy Vitamin D Levels
Hide Description As assessed via serum blood samples.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: ng/ml
23.21  (8.91) 27.58  (16.38)
44.Secondary Outcome
Title Tumor Necrosis Factor-alpha (TNFα)
Hide Description Analysis of TNFα in peripheral blood plasma
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 11 11
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
349
(228 to 407)
451
(368 to 1730)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0356
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
45.Secondary Outcome
Title Tumor Necrosis Factor-beta (TNFβ)
Hide Description Analysis of TNFβ in peripheral blood plasma
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 11 11
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
829
(494 to 1260)
1540
(852 to 5890)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0215
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
46.Secondary Outcome
Title Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)
Hide Description Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw and data was unavailable for two patients.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 11 9
Mean (Standard Deviation)
Unit of Measure: pg/mL
26609.09  (3071.96) 23111.11  (3086.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0210
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3498
Confidence Interval (2-Sided) 95%
-6404.7 to -591.2
Parameter Dispersion
Type: Standard Deviation
Value: 3078.2
Estimation Comments [Not Specified]
47.Secondary Outcome
Title Viral Load by SARS-CoV-2 RT-PCR
Hide Description Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 10 11
Median (Inter-Quartile Range)
Unit of Measure: RNA copies/mL
0
(0 to 0)
0
(0 to 2193)
48.Secondary Outcome
Title Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion
Hide Description Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Time Frame day 3 post first infusion
Hide Outcome Measure Data
Hide Analysis Population Description
One subject in the control group died before day 3 post first infusion.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 12 11
Measure Type: Count of Participants
Unit of Measure: Participants
Class I PRA Positive
10
  83.3%
11
 100.0%
PRA Negative
2
  16.7%
0
   0.0%
Class II PRA Positive
4
  33.3%
6
  54.5%
PRA Negative
8
  66.7%
5
  45.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments The null hypothesis is the following: "There is no association between PRA (class I) status and treatment group at 3 days post first infusion".
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments The null hypothesis is the following: "There is no association between PRA (class II) status and treatment group at 3 days post first infusion."
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
49.Secondary Outcome
Title Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion
Hide Description Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Time Frame day 6
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC group one patient was censored and died before day 6 and one patient recovered before day 6 and left the hospital. In the control group on patient died before day 6 post first infusion.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
Class I PRA Positive
9
  90.0%
9
  81.8%
PRA Negative
1
  10.0%
2
  18.2%
Class II PRA Positive
5
  50.0%
5
  45.5%
PRA Negative
5
  50.0%
6
  54.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments The null hypothesis is the following: "There is no association between PRA (class I) status and treatment group at 6 days post first infusion".
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments The null hypothesis is the following: "There is no association between PRA (Class II) status and treatment group at 6 days post first infusion".
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
50.Secondary Outcome
Title Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion
Hide Description Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Time Frame day 14
Hide Outcome Measure Data
Hide Analysis Population Description
In the UC-MSC group one patient was censored and died before day 6, 6 patients left the hospital before day 6 post first infusion. In the control group 4 patients died, 3 patients left the hospital and one left hospital against medical advice before day 6 post first infusion.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Class I PRA Positive
5
 100.0%
3
  75.0%
PRA Negative
0
   0.0%
1
  25.0%
Class II PRA Positive
4
  80.0%
2
  50.0%
PRA Negative
1
  20.0%
2
  50.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments The null hypothesis is the following: "There is no association between PRA (class I) status and treatment group at 14 days post first infusion".
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection UC-MSCs Group, Control Group
Comments The null hypothesis is the following: "There is no association between PRA (class II) status and treatment group at 14 days post first infusion".
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5238
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
51.Secondary Outcome
Title Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG
Hide Description Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples.
Time Frame day 14 post first infusion
Hide Outcome Measure Data
Hide Analysis Population Description
These analyses were implemented in a protocol version that did not apply to 2 patients of the UC-MSC treatment group and 3 patients of the control group. In the UC-MSC group one patient was censored and died before day 6, 4 patients left the hospital before day 6 post first infusion and in one patient blood was not drawn. In the control group 3 patients died, 3 patients left the hospital and one left hospital against medical advice before day 6 post first infusion.
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description:

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

Overall Number of Participants Analyzed 4 2
Measure Type: Count of Participants
Unit of Measure: Participants
IgM Positive
2
  50.0%
2
 100.0%
Negative
1
  25.0%
0
   0.0%
Borderline
1
  25.0%
0
   0.0%
IgG Positive
4
 100.0%
2
 100.0%
Negative
0
   0.0%
0
   0.0%
Borderline
0
   0.0%
0
   0.0%
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title UC-MSCs Group Control Group
Hide Arm/Group Description

Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.

Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.

Vehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.

All-Cause Mortality
UC-MSCs Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   3/12 (25.00%)      7/12 (58.33%)    
Hide Serious Adverse Events
UC-MSCs Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      8/12 (66.67%)    
Cardiac disorders     
Cardiact Arrest-Death due to Difficult Intubation  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Atrial Flutter  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Cardiac Arrest/Pulseless Electrical Activity Cardiac Arrest/Cardiac Arrest Secondary to Acute Respir  1  0/12 (0.00%)  0 3/12 (25.00%)  3
[DEATH] Cardiac Arrest-Death/Cardiopulmonary Arrest-Death/Asystole -Death  1  1/12 (8.33%)  1 4/12 (33.33%)  4
Gastrointestinal disorders     
GI Bleeding 2ry to Clostridium Difficile Infection  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Colon Perforation  1  1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders     
[DEATH] Multisystem Organ Failure (Death)/Multiple Organ Dysfunction Syndrome-Death  1  0/12 (0.00%)  0 2/12 (16.67%)  2
Infections and infestations     
Septic Shock-Hospital acquired Pseudomona Aeruginosa bacteremia  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Metabolism and nutrition disorders     
Hyperkalemia  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Severe Metabolic Acidosis  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Psychiatric disorders     
Psychosis  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory Failure 2ry to COVID-Death  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Death-Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Pneumonitis  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Traumatic Tension Pneumotorax post-CPR  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Severe Respiratory Acidosis  1  0/12 (0.00%)  0 1/12 (8.33%)  1
1
Term from vocabulary, CTCAE Version 5.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
UC-MSCs Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/12 (66.67%)      10/12 (83.33%)    
Blood and lymphatic system disorders     
Anemia  1  0/12 (0.00%)  0 2/12 (16.67%)  2
Leukocytosis/Leukocytosis (Increased WBC)  1  3/12 (25.00%)  3 3/12 (25.00%)  3
Severe Thrombocytopenia  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Thrombocytopenia/Heparin-induced Thrombocytopenia  1  2/12 (16.67%)  2 0/12 (0.00%)  0
Thrombocytosis  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Cardiac disorders     
Atrial Fibrillation  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Bradycardia  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Tachycardia  1  2/12 (16.67%)  2 0/12 (0.00%)  0
Tachycardia after infusion of Investigational Product  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Endocrine disorders     
Hyperglycemia  1  0/12 (0.00%)  0 2/12 (16.67%)  2
Gastrointestinal disorders     
Clostridium Difficile Infection  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Mild Gastrointestinal Bleeding  1  1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders     
Fever  1  3/12 (25.00%)  3 2/12 (16.67%)  2
Hepatobiliary disorders     
Transaminitis/Transaminitis-Liver Shock  1  0/12 (0.00%)  0 2/12 (16.67%)  3
Increased ALT, AST, and Alkaline Phosphatase  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Increased Direct Bilirubin  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations     
Exacerbation of COVID ARDS-Septic Shock  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Candida Albicans Fungemia  1  1/12 (8.33%)  1 0/12 (0.00%)  0
MRSA Bacteremia  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Paenebacillus Pabuli Bacteremia  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Positive Blood Culture Streptococcus Mitis and Streptococcus Oralis  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Staphylococcus haemolyticus bacteremia and Candida orthopsilosi Fungemia  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Staphylococcus Hominis Bacteremia/Staphylococcus Bacteremia  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Metabolism and nutrition disorders     
Hypernatremia  1  2/12 (16.67%)  2 0/12 (0.00%)  0
Mild Hyponatremia  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Hypokalemia  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Hyperkalemia  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Left Calf Collection  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorders     
Encephalopathy  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Dysconjugated gaze  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Renal and urinary disorders     
Abnormal Urinalysis  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Candiduria  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Urinary Tract Infection  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Acute Kidney Injury/Oliguric Acute Kidney Injury/ Anuric Acute Kidney Injury/Acute Kidney Injury (AK  1  2/12 (16.67%)  2 5/12 (41.67%)  5
Respiratory, thoracic and mediastinal disorders     
Pneumoperitoneum  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Aspiration Pneumonitis, suspected  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Bradypnea  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Enterococcus Faecalis, Klebsiella Pneumoniae, Candida Auris/Duobushaemulonis in bronchial aspirate  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Enterococcus Pneumonia  1  1/12 (8.33%)  1 0/12 (0.00%)  0
MRSA Hospital Acquired Pneumonia  1  2/12 (16.67%)  2 0/12 (0.00%)  0
Pneumomediastinum  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Respiratory Failure - Intubation/Hypoxemic respiratory failure requiring intubation and mechanical v  1  1/12 (8.33%)  1 1/12 (8.33%)  1
Subcutaneous Emphysema  1  1/12 (8.33%)  1 0/12 (0.00%)  0
Ventilator Acquired Pneumonia (VAP) with Pseudomona aureginosa  1  0/12 (0.00%)  0 1/12 (8.33%)  1
Worsening of Hypoxemia/Deterioration of Hypoxia  1  4/12 (33.33%)  4 0/12 (0.00%)  0
Vascular disorders     
Bilateral Common Femoral Vein DVT  1  0/12 (0.00%)  0 1/12 (8.33%)  1
1
Term from vocabulary, CTCAE Version 5.0
Indicates events were collected by systematic assessment
The inferences we make from the efficacy results observed in this phase 1/2a trial in 24 subjects, including the outcome of survival, are still subject to limitations of sample size and potential bias because of factors we were not yet aware of.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Camillo Ricordi
Organization: University of Miami
Phone: 305-243-6913
EMail: ricordi@miami.edu
Layout table for additonal information
Responsible Party: Camillo Ricordi, University of Miami
ClinicalTrials.gov Identifier: NCT04355728    
Other Study ID Numbers: 20200671
20200370 ( Other Identifier: Secondary Protocol ID )
First Submitted: April 13, 2020
First Posted: April 21, 2020
Results First Submitted: October 15, 2021
Results First Posted: December 6, 2021
Last Update Posted: December 6, 2021