Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndro
Brief Summary: This is a Phase 2, 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 Stem Cells infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774). Patients will be randomized to receive Human Mesenchymal Stem Cells infusion or placebo in a 2:1 allocation. Patients will be followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status will be collected at 6 and 12 months after study enrollment.