Clinical Trial: Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Phase 1 Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndrome
Brief Summary: This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of hMSCs in patients with ARDS.
Detailed Summary: The primary objective of this study is to assess the safety of intravenous infusion of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) in patients with ARDS.
Sponsor: Michael A. Matthay
Current Primary Outcome: Comparison of treatment adverse event rates between the 1, 5 and 10 million cells per kilogram dose cohorts [ Time Frame: 12 months ]
Original Primary Outcome: Safety [ Time Frame: 7 days ]
Current Secondary Outcome:
Original Secondary Outcome: Safety [ Time Frame: Up to 12 months ]
Information By: University of California, San Francisco
Dates:
Date Received: January 18, 2013
Date Started: July 2013
Date Completion: February 2017
Last Updated: August 14, 2014
Last Verified: August 2014