CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02097641
NCT02097641Phase 2Completed
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Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

Michael A. Matthay·interventional·Posted Mar 27, 2014·Updated Apr 10, 2019

In Brief

A Phase 2 clinical trial evaluating Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells and Plasma-Lyte A for Respiratory Distress Syndrome, Adult. Completed, enrolled 60 participants across 6 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Distress Syndrome, Adult
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Massachusetts General Hospital, Stanford University, University of Pittsburgh, University of Minnesota, Ohio State University

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 27, 2014
Enrollment StartMar 15, 2014
Primary CompletionMar 9, 2017
Study CompletionFeb 9, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.3 years ago

Interventions

Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cellsbiological

Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes.

Plasma-Lyte Abiological

Plasma-Lyte A placebo was administered intravenously over approximately 60-80 minutes.