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)

Authors

• Michael A Matthay
• Hanjing Zhou
• Aartik Sarma
• Narges Alipanah-Lechner
• Carolyn Hendrickson
• Lucy Z Kornblith
• Martin Schreiber
• David Zonies
• Akram Khan
• Bryce Robinson
• Nicholas J Johnson
• Lorraine B Ware
• Oscar Guillamondegui
• Jonathan Casey
• Laura Moore
• Bela Patel
• Lillian Kao
• Charles E Wade
• Erin Fox
• Charles Cox
• Farrakh Khawanja
• Robier Aguillon Prada
• Sami Hossri
• Rachael Callcut
• Timothy Albertson
• Kevin L Delucchi
• Melanie McMillan
• Charles R Langelier
• Shibani Pati
• David H McKenna
• Carolyn Leroux
• Carolyn S Calfee
• Kathleen D Liu

Language

English

Publication Date

7-29-2025

Journal

American Journal of Respiratory and Critical Care Medicine

DOI

10.1164/rccm.202411-2254OC

PMID

40728562

PMCID

PMC12360293

PubMedCentral® Posted Date

4-19-2025

PubMedCentral® Full Text Version

Author MSS

Abstract

Background: Prior clinical trials established the safety, but not the efficacy of bone marrow-derived mesenchymal stromal cells (MSCs) in the acute respiratory distress syndrome (ARDS).

Methods: We conducted a prospective, double-blind, multi-center randomized phase 2b clinical trial of one dose of intravenous MSCs (10 x 106/kg predicted body weight) versus placebo in 120 ventilated patients with ARDS (PaO2/FiO2 < 250 mmHg). The primary endpoint was change in oxygenation index (OI) over 36 hours from baseline.

Findings: Enrollment began in January 2020. Due to the Coronavirus 2019 (COVID-19) pandemic, the majority of subjects (101/120, 84%) developed ARDS from COVID-19. There were no significant baseline differences in severity of illness between patients treated with MSCs and those who received placebo in the entire cohort of 120 patients or in the 101 patients with COVID-19 ARDS. There was no difference in the primary endpoint of change in oxygenation index from baseline over 36 hours after study product administration for the entire cohort or the COVID-19 subgroup, nor were there significant differences in mortality at 14, 28, 60 or 180 days. Plasma protein biomarker and gene expression analyses identified sub-groups of patients with differential treatment responses in terms of clinical outcomes.

Interpretation: This phase 2b clinical trial identified no physiologic or clinical benefit from a single dose of MSCs in patients with ARDS, including those with COVID-19 ARDS. In future trials, baseline plasma biological markers may help identify patients who are more likely to benefit from MSCs therapy.

Comments

Clinicaltrials: gov, ID: NCT03818854.

Published Open-Access

yes

Recommended Citation

Matthay, Michael A; Zhou, Hanjing; Sarma, Aartik; et al., "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)" (2025). Faculty, Staff and Student Publications. 3509.
https://digitalcommons.library.tmc.edu/uthmed_docs/3509