MSCs in COVID-19 ARDS
Public ClinicalTrials.gov record NCT04371393. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Mesenchymal Stromal Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.
Study identification
- NCT ID
- NCT04371393
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 223 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2020 (Actual)
- Primary completion
- Jan 14, 2021 (Actual)
- Completion
- Jan 2, 2022 (Actual)
- Last update posted
- Apr 25, 2022
2020 – 2022
United States locations
- U.S. sites
- 21
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dignity Health | Gilbert | Arizona | 85297 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Stanford University | Stanford | California | 94305 | — |
| Emory University | Atlanta | Georgia | 30308 | — |
| Lutheran Hospital | Fort Wayne | Indiana | 46825 | — |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Dartmouth-Hitchcock | Lebanon | New Hampshire | 03766 | — |
| New York University Langone Health | New York | New York | 10016 | — |
| Mount Sinai Health | New York | New York | 10029 | — |
| Northwell Health | New York | New York | 10075 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| WakeMed | Raleigh | North Carolina | 27610 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Baylor, Smith & White | Plano | Texas | 75093 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04371393, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 25, 2022 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04371393 live on ClinicalTrials.gov.