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Use of Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Caused by COVID-19

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: NCT04456361
Recruitment Status : Active, not recruiting
First Posted : July 2, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto de Medicina Regenerativa

Brief Summary:
This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and follow-up will occur 90 days post-treatment.

Condition or disease Intervention/treatment Phase
ARDS, Human Covid-19 Biological: Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Mesenchymal Stem Cells as a Treatment in Patients With Acute Respiratory Distress Syndrome Caused by COVID-19
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : December 15, 2020


Arm Intervention/treatment
Experimental: COVID-19 patients
Treatment consistsof Mesenchymal Stem Cells administered as a one-time, single-dose therapy via IV infusion at a dose of 1 X 10 8 cells.
Biological: Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords
Mesenchymal Stem Cells as a single-dose therapy via IV infusion at a dose of 1 X 10 8 cells.
Other Name: UCMSC




Primary Outcome Measures :
  1. Oxygen saturation [ Time Frame: Baseline, and at days 2, 4 and 14 post-treatment ]
    Number of patients with changes in percentage of resting Oxygen saturation (%O2)


Secondary Outcome Measures :
  1. Oxygen pressure in inspiration [ Time Frame: Baseline, and at days 2, 4 and 14 post-treatment ]
    Changes in mmHg of Arterial partial pressure of oxygen / Fraction of inspiration O2 (PaO2/FiO2) in all participants

  2. ground-glass opacity [ Time Frame: Baseline, and at day 14 post-treatment ]
    Changes in percentage of participants with reduction in bilateral ground-glass opacities

  3. Pneumonia infiltration [ Time Frame: Baseline, and at day 14 post-treatment ]
    Changes in percentage of participants with reduction of pneumonia bilateral infiltration

  4. Lactate dehydrogenase [ Time Frame: Baseline, and at days 4 and 14 post-treatment ]
    Number of participants with a reduction in Lactate dehydrogenase (mg/dL)

  5. C-reactive protein [ Time Frame: Baseline, and at days 4 and 14 post-treatment ]
    Number of participants with a reduction in C-reactive protein (mg/dL)

  6. D-dimer [ Time Frame: Baseline, and at days 4 and 14 post-treatment ]
    Number of participants with a reduction in D-dimer (mg/dL)

  7. Ferritine [ Time Frame: Baseline, and at days 4 and 14 post-treatment ]
    Number of participants with a reduction in Ferritine (mg/dL)



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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:

  • Ability to understand and the willingness to provide informed consent or a legally authorized representative.
  • Diagnosis of Acute Respiratory Distress Syndrome according to the Berlin Definition following the failing of prior standard therapy, and other available therapies.

Mild: 200 mm Hg < PaO2/FIO2 ≤ 300 mm Hg with PEEP or CPAP ≥ 5 cm H2Oc Moderate: 100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg with PEEP ≥ 5 cm H2O Severe: PaO2/FIO2 ≤ 100 mm Hg with PEEP ≥ 5 cm H2O

  • Diagnostic test positive for SARS-CoV-2
  • Age ≥ 18 years
  • Any man with a partner of child-bearing potential agrees to use adequate contraception which will include two of the following: hormonal or barrier method of birth control, or abstinence prior to study entry, for the duration of study participation, and for 30 days following completion of therapy.

Exclusion Criteria:

  • Current or anticipated use of other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MSC infusion plus any patently atopic patients who have a history of having experienced an episode of allergic anaphylaxis.
  • Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease).
  • Known diagnosis of human immunodeficiency virus (HIV) infection.

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): NCT04456361


Locations
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Mexico
Instituto de Medicina Regenerativa
Tijuana, Baja California, Mexico, 22100
Sponsors and Collaborators
Instituto de Medicina Regenerativa
Investigators
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Principal Investigator: Jesus Perez Instituto de Medicina Regenerativa
Study Chair: Juan Parcero Instituto de Medicina Regenerativa
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Responsible Party: Instituto de Medicina Regenerativa
ClinicalTrials.gov Identifier: NCT04456361    
Other Study ID Numbers: MSC-ARDS-001
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury