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

NCT02097641 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-04-10

Study results available
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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).

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Massachusetts General Hospital

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Michael A. Matthay

    lead OTHER

Principal Investigators

  • Michael A Matthay, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-15
Primary Completion
2017-03-09
Completion
2018-02-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02097641 on ClinicalTrials.gov