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NCT02097641 · ClinicalTrials.gov registry record · Phase 2
Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)
A Phase 2 study, sponsored by Michael A. Matthay.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT02097641: Completed Phase 2 study, sponsored by Michael A. Matthay.
NCT02097641 is a Phase 2 study that has completed, run by Michael A. Matthay. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02097641, a Phase 2 study, has completed, sponsored by Michael A. Matthay.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial 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).
Primary Outcome
Within 6 h of study product infusion: * Increase in vasopressor dose to the following values or higher: * Norepinephrine 10 μg/min * Phenylephrine 100 μg/min * Dopamine 10 μg/kg per min * Epinephrine 0.1 μg/kg per min or addition of a third vasopressor * New ventricular tachycardia, ventricular fibrillation or asystole * New cardiac arrhythmia requiring cardioversion * Hypoxaemia requiring an increase in FiO2 of 0·2 or more and an increase in PEEP of 5·0 or more to maintain SpO2 in the target r
Interventions
- BIOLOGICAL Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells
- BIOLOGICAL Plasma-Lyte A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-03-15 |
| Est. Completion | 2018-02-09 |
| Phase | Phase 2 |
What the finished NCT02097641 record still lists
NCT02097641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells is the first listed.
NCT02097641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02097641 about?
NCT02097641 is a clinical study titled "Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)". This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial 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).
What is the current status of trial NCT02097641?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2014-03-15. Estimated completion is 2018-02-09.
What interventions are being tested in trial NCT02097641?
The interventions under investigation include: Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells (BIOLOGICAL), Plasma-Lyte A (BIOLOGICAL).
Who is sponsoring clinical trial NCT02097641?
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 NCT02097641's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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