At a glance
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A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome
In Brief
A Phase 2 clinical trial evaluating Human Mesenchymal Stromal Cells and Cell Reconstitution Media for Respiratory Distress Syndrome, Adult. Completed, enrolled 120 participants across 7 sites.
Detailed 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).
Study Details
Timeline
Interventions
Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.
300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)