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 ]

Incidence of pre-specified infusion associated events occurring within 6 hours of administration of hMSCs and of unexpected severe adverse events in ARDS patients treated with hMSCs for 7 days.


Current Secondary Outcome:

Original Secondary Outcome: Safety [ Time Frame: Up to 12 months ]

Unexpected adverse events 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