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Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome

NCT03818854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-04

Study results available
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Summary

This is a Phase 2b, 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 Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774) and Phase 2a study (NCT02097641).

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

BIOLOGICAL

Human Mesenchymal Stromal Cells

Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.

BIOLOGICAL

Cell Reconstitution Media

300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Harborview Injury Prevention and Research Center

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Michael A. Matthay

    lead OTHER

Principal Investigators

  • Michael 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
2019-11-26
Primary Completion
2024-03-30
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03818854 on ClinicalTrials.gov