A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome

Who is this study for? Patients with acute respiratory distress syndrome
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients will be eligible for inclusion if they meet all of the below criteria within 14 days of initial ICU admission. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:

• Acute onset (defined below) of:

• A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio <250 mmHg and ≥5 cm H2O positive end-expiratory airway pressure (PEEP), as per the Berlin Criteria.

• Bilateral infiltrates consistent with pulmonary edema (defined below) on the frontal chest radiograph, or bilateral ground glass opacities on a chest CT scan.

• No clinical evidence of left atrial hypertension as a primary explanation for the bilateral pulmonary infiltrates.

• If the cause of ARDS is trauma, additional inclusion criteria will include ONE of the following relevant risk factors for developing ARDS:

• Hypotension (systolic blood pressure[SBP] < 90 mmHg) in the field or in the first 24 h after injury, or

• Transfusion of 3 units of blood products in the first 24 hours following injury, or

• Meets the new Critical Administration Threshold (CAT) criteria with at least 3 units of blood in one hour, or

• Blunt or penetrating torso trauma, or

• Long bone fractures, or

• The highest level of institutional trauma activation

Locations
United States
California
University of California Davis Medical Center
Recruiting
Sacramento
University of California San Francisco
Recruiting
San Francisco
Zuckerberg San Francisco General Hospital and Trauma Center
Recruiting
San Francisco
Oregon
Oregon Health & Science University
Recruiting
Portland
Tennessee
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Memorial Hermann Hospital - Texas Medical Center
Recruiting
Houston
Washington
Harborview Medical Center
Recruiting
Seattle
Contact Information
Primary
Michael Matthay, MD
michael.matthay@ucsf.edu
415-353-1206
Backup
Hanjing Zhuo, MPH
hanjing.zhuo@ucsf.edu
415-502-7434
Time Frame
Start Date: November 26, 2019
Estimated Completion Date: July 1, 2024
Participants
Target number of participants: 120
Treatments
Experimental: Human Mesenchymal Stromal Cells
A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes.
Experimental: Cell Reconstitution Media
A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes.
Authors
Oscar Guillamondegui, Kathleen D Liu, Carolyn M Hendrickson, Joseph Cuschieri, Jeffrey E Gotts, Lillian Kao, Lorraine B Ware, Kirsten N Kangelaris, David Zonies, Charles E Wade, Lucy Kornblith, Jonathan Casey, Carolyn S Calfee, Rachael Callcut, Charles Cox, Bryce Robinson, Timothy Albertson, Michael A Matthay, Bela Patel, John Holcomb, Laura H Moore, Farrakh Khawanja, Nick Johnson, Erin Fox, Martin Schreiber, Akram Khan, Terri Hough
Sponsors
Leads: Michael A. Matthay
Collaborators: Oregon Health and Science University, United States Department of Defense, The University of Texas Health Science Center, Houston, Vanderbilt University Medical Center, University of Minnesota, Harborview Injury Prevention and Research Center

This content was sourced from clinicaltrials.gov

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