Clinical Trial: Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome (START)
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.
Detailed Summary:
Sponsor: Michael A. Matthay
Current Primary Outcome:
- Incidence of pre-specified infusion associated events occurring within 6 hours of study infusion [ Time Frame: 6 hours ]
- Any cardiac arrest or death within 24 hours of study infusion [ Time Frame: 24 hours ]
- Any unexpected severe adverse events in two groups [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Respiratory efficacy endpoints which include lung injury score, PaO2/FiO2 ratio and oxygenation index at day 3. [ Time Frame: 28 days ]
- Systemic efficacy endpoints which include SOFA score, ventilator-free days, organ failure free days, mortality, et al. [ Time Frame: 60 days ]
- Biological efficacy endpoints which includes serial levels of plasma and urine biomarkers. [ Time Frame: 3 days ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: March 19, 2014
Date Started: March 15, 2014
Date Completion: February 9, 2018
Last Updated: May 2, 2017
Last Verified: May 2017