Use of Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Caused by COVID-19
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ClinicalTrials.gov Identifier: NCT04456361 |
Recruitment Status :
Active, not recruiting
First Posted : July 2, 2020
Last Update Posted : August 4, 2022
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Condition or disease | Intervention/treatment | Phase |
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ARDS, Human Covid-19 | Biological: Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords | Early Phase 1 |

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, 2022 |
Estimated Study Completion Date : | December 15, 2022 |

Arm | Intervention/treatment |
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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.
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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 |
- 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)
- 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
- ground-glass opacity [ Time Frame: Baseline, and at day 14 post-treatment ]Changes in percentage of participants with reduction in bilateral ground-glass opacities
- Pneumonia infiltration [ Time Frame: Baseline, and at day 14 post-treatment ]Changes in percentage of participants with reduction of pneumonia bilateral infiltration
- Lactate dehydrogenase [ Time Frame: Baseline, and at days 4 and 14 post-treatment ]Number of participants with a reduction in Lactate dehydrogenase (mg/dL)
- 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)
- D-dimer [ Time Frame: Baseline, and at days 4 and 14 post-treatment ]Number of participants with a reduction in D-dimer (mg/dL)
- 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 |
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.

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
Mexico | |
Instituto de Medicina Regenerativa | |
Tijuana, Baja California, Mexico, 22100 |
Principal Investigator: | Jesus Perez | Instituto de Medicina Regenerativa | |
Study Chair: | Juan Parcero | Instituto de Medicina Regenerativa |
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, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |