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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355728
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Camillo Ricordi, University of Miami

Brief Summary:
The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).

Condition or disease Intervention/treatment Phase
Corona Virus Infection ARDS ARDS, Human Acute Respiratory Distress Syndrome COVID-19 Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care. Other: Vehicle + Heparin along with best supportive care Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial has two groups, each with 12 subjects (n=24). All eligible subjects will be randomized to either the treatment group or standard of care, and randomization will be stratified by ARDS severity.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-Blinding Trial
Primary Purpose: Treatment
Official Title: Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)
Actual Study Start Date : April 25, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 1, 2022


Arm Intervention/treatment
Experimental: UC-MSCs Group
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.
Biological: 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.

Placebo Comparator: Control Group
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.
Other: Vehicle + Heparin along with best supportive care
Best supportive care treatment per the treating hospital protocol.




Primary Outcome Measures :
  1. Incidence of pre-specified infusion associated adverse events [ Time Frame: Day 5 ]
    Safety will be defined by the incidence of pre-specified infusion associated adverse events as assessed by treating physician

  2. Incidence of Severe Adverse Events [ Time Frame: 90 days ]
    Safety will be defined by the incidence of severe adverse events as assessed by treating physician


Secondary Outcome Measures :
  1. Survival rate after 90 days post first infusion [ Time Frame: 90 days ]
    Number of participants that are alive at 90 days post first infusion follow up.

  2. Ventilator-Free Days [ Time Frame: 28 days or hospital discharge, whichever is earlier ]
    Number of days participants were off ventilators within up to 28 days of hospitalization

  3. Change in Oxygenation Index (OI) [ Time Frame: 28 days ]
    Measure the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy).

  4. Plat-PEEP [ Time Frame: 28 days ]
    Measuring respiratory mechanics in ventilated patients [plateau pressure (Pplat)-positive end-expiratory pressure]

  5. Sequential Organ Failure Assessment (SOFA) Scores [ Time Frame: 28 days ]
    The SOFA assessment 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 0 (normal) to 4 (high degree of dysfunction/failure)

  6. Small Identification Test (SIT) scores [ Time Frame: At baseline, day 18 and day 28. ]
    The SIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The test has a total score ranging from 0-40 Follows scoring key for evaluation. The higher score indicates better outcome.

  7. Troponin I levels [ Time Frame: Baseline, 28 days ]
    As assessed via serum blood samples.

  8. C-Reactive Protein levels [ Time Frame: Baseline, 28 days ]
    As assessed via serum blood samples.

  9. Arachidonic Acid (AA)/Eicosapentaenoic Acid (EPA) Ratio [ Time Frame: Baseline, 28 days ]
    As assessed via serum blood samples.

  10. D-dimer levels [ Time Frame: Baseline, 28 days ]
    As assessed via serum blood samples.

  11. 25-Hydroxy Vitamin D levels [ Time Frame: Baseline, 28 days ]
    As assessed via serum blood samples.

  12. Alloantibodies levels [ Time Frame: Baseline, 28 days ]
    As assessed via serum blood samples.

  13. Blood white cell count [ Time Frame: Baseline, 28 days ]
    As assessed via serum blood samples.

  14. Platelets count [ Time Frame: Baseline, 28 days ]
    As assessed via serum blood samples.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients >/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below criteria. Inclusion criteria must all be present within a 24-hour time period at the time of enrollment:

  1. Patient currently hospitalized
  2. Aged ≥ 18 years
  3. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
  4. Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
  5. PaO2/FiO2 ratio < 300 mmHg
  6. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
  7. Hypoxemia requiring an increase in the fraction of inspired oxygen (FiO2) of ≥ 20% AND an increase in positive end-expiratory airway pressure (PEEP) level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation

Exclusion Criteria:

  1. PaO2/FiO2 ≥ 300 at the time of enrollment
  2. A previous MSC infusion not related to this trial
  3. History of Pulmonary Hypertension (WHO Class III/IV)
  4. History of left atrial hypertension or decompensated left heart failure.
  5. Pregnant or lactating patient
  6. Unstable arrhythmia
  7. Patients with previous lung transplant
  8. Patients currently receiving chronic dialysis
  9. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
  10. Presence of any active malignancy (except non-melanoma skin cancer)
  11. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
  12. Moderate to severe liver disease (AST and ALT >5 X ULN)
  13. Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
  14. Baseline QT prolongation
  15. Moribund patient not expected to survive > 24 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355728


Contacts
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Contact: Camillo Ricordi, MD 305-243-6913 cricordi@miami.edu

Locations
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United States, Florida
Diabetes Research Institute, University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Rodolfo Alejandro, M.D.    (305) 243-5324    ralejand@med.miami.edu   
Contact: Khemraj Hirani, MPharm PhD RPH    (305) 243-5312    khirani@med.miami.edu   
Sub-Investigator: Rodolfo Alejandro, M.D.         
Sub-Investigator: David A Baidal, M.D.         
Sponsors and Collaborators
Camillo Ricordi
Investigators
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Principal Investigator: Camillo Ricordi, MD University of Miami
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Responsible Party: Camillo Ricordi, Professor of Surgery and Chief, Division of Cellular Transplantation, University of Miami
ClinicalTrials.gov Identifier: NCT04355728    
Other Study ID Numbers: 20200671
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camillo Ricordi, University of Miami:
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Virus Diseases
Lung Injury
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action