Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome

NCT03818854 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UCSF-hMSC-ARDS-P1P2-12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Human Mesenchymal Stromal Cells; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Oxygenation Index (OI)

  Change in OI from baseline over the 36 hours (6, 12, 18, 24, 30, 36 hours) following the initiation of the study product infusion. Lower values are considered better.

  36 hours

Secondary Outcomes (26)

• Acute Lung Injury Score (LIS)

  7 days

• Pulmonary Dead Space Fraction

  7 days

• Change of Chest Radiograph Assessment of Pulmonary Edema (RALE Score)

  7 days

• Ventilator Free-days (VFD) Over 14 Days

  14 days

• Ventilator Free-days (VFD) Over 28 Days.

  28 days

Study Arms (2)

Human Mesenchymal Stromal Cells

EXPERIMENTAL

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.

Biological: Human Mesenchymal Stromal Cells

Cell Reconstitution Media

EXPERIMENTAL

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.

Biological: Cell Reconstitution Media

Interventions

Human Mesenchymal Stromal Cells BIOLOGICAL

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.

Also known as: hMSCs

Human Mesenchymal Stromal Cells

Cell Reconstitution Media BIOLOGICAL

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

Also known as: Placebo

Cell Reconstitution Media

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Age less than 18 years
• Greater than 72 hours since first meeting ARDS criteria per the Berlin definition of ARDS
• Greater than 14 days since initial ICU admission
• Inability to administer study product within 14 days of ICU admission
• PaO2/FiO2 ≥ 250 mmHg after consent obtained and before study product is administered
• Unable to obtain informed consent/no surrogate available
• Pregnant or lactating
• In custody of law enforcement officials
• Burns \> 20% of total body surface area
• WHO Class III or IV pulmonary hypertension
• History of cancer treatment in the last 2 years except for non-melanotic skin cancers
• Underlying medical condition for which 6-month mortality is estimated to be \> 50%
• Moribund patient not expected to survive 24 hours
• Advanced chronic liver disease (Child-Pugh Score \> 12)
• Severe chronic respiratory disease with the use of home oxygen

Sponsors & Collaborators

• Michael A. Matthay: lead
• United States Department of Defense: collaborator
• Harborview Injury Prevention and Research Center: collaborator
• Oregon Health and Science University: collaborator
• Vanderbilt University Medical Center: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• University of Minnesota: collaborator

Study Sites (7)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

Harborview Medical Center

Seattle, Washington, 98112, United States

Location

Related Publications (1)

• Matthay MA, Zhou H, Sarma A, Alipanah-Lechner N, Hendrickson C, Kornblith LZ, Schreiber M, Zonies D, Khan A, Robinson B, Johnson NJ, Ware LB, Guillamondegui O, Casey J, Moore L, Patel B, Kao L, Wade CE, Fox E, Cox C, Khawanja F, Aguillon Prada R, Hossri S, Callcut R, Albertson T, Delucchi KL, McMillan M, Langelier CR, Pati S, McKenna DH, Leroux C, Calfee CS, Liu KD. Treatment with Allogenic Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome: A Double-Blind, Placebo-controlled, Multi-Center, Phase 2b Clinical Trial (STAT). Am J Respir Crit Care Med. 2025 Jul 29:10.1164/rccm.202411-2254OC. doi: 10.1164/rccm.202411-2254OC. Online ahead of print.

  PMID: 40728562 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Dr. Michael Matthay
• Organization: University of California San Francisco

michael.matthay@ucsf.edu

415-476-1079

Study Officials

• Michael Matthay, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: For this Phase 2b trial, after informed consent is given, an assignment will be made by computer-generated randomization to administer either hMSCs therapy or placebo with a 1:1 allocation to the hMSCs:placebo arms.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: November 26, 2019
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)