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NCT03818854 · ClinicalTrials.gov registry record · Phase 2
Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome
A Phase 2 study, sponsored by Michael A. Matthay.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT03818854: Completed Phase 2 study, sponsored by Michael A. Matthay.
NCT03818854 is a Phase 2 study that has completed, run by Michael A. Matthay. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03818854, a Phase 2 study, has completed, sponsored by Michael A. Matthay.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774) and Phase 2a study (NCT02097641).
Primary Outcome
Change in OI from baseline over the 36 hours (6, 12, 18, 24, 30, 36 hours) following the initiation of the study product infusion. Lower values are considered better.
Interventions
- BIOLOGICAL Human Mesenchymal Stromal Cells
- BIOLOGICAL Cell Reconstitution Media
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 2 |
What the finished NCT03818854 record still lists
NCT03818854 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Human Mesenchymal Stromal Cells is the first listed.
NCT03818854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03818854 about?
NCT03818854 is a clinical study titled "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome". This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the ex...
What is the current status of trial NCT03818854?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2019-11-26. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT03818854?
The interventions under investigation include: Human Mesenchymal Stromal Cells (BIOLOGICAL), Cell Reconstitution Media (BIOLOGICAL).
Who is sponsoring clinical trial NCT03818854?
This trial is sponsored by Michael A. Matthay, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03818854's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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