NCT02097641

Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)

Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Michael A. Matthay · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial 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).

Detailed description

We carried out a randomized, double-blind placebo-controlled trial of allogeneic bone marrow derived human mesenchymal stromal cells for treatment of moderate to severe ARDS in 60 patients, 40 MSC and 20 placebo, in a 2:1 randomization. This trial is the extension of the Phase 1 pilot trial (NCT01775774). Patients were followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status was collected at 6 and 12 months after study enrollment.

Conditions

• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells	Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes.
BIOLOGICAL	Plasma-Lyte A	Plasma-Lyte A placebo was administered intravenously over approximately 60-80 minutes.

Timeline

• Start date: 2014-03-15
• Primary completion: 2017-03-09
• Completion: 2018-02-09
• First posted: 2014-03-27
• Last updated: 2019-04-10
• Results posted: 2019-04-10

Locations

6 sites across 1 country: United States