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).

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

SUBMITTER: Matthay MA 

PROVIDER: S-EPMC12360293 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature