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Allogeneic bone marrow-derived human mesenchymal stromal cells (hMSCs) are an investigational cell-based therapy being evaluated for the treatment of moderate to severe acute respiratory distress syndrome (ARDS). Developed under the leadership of Michael A. Matthay at the University of California, San Francisco, and sourced through the NHLBI's Production Assistance for Cellular Therapies (PACT) program, these cells are administered via a single intravenous infusion. The therapeutic rationale is based on the ability of MSCs to home to sites of injury and secrete a variety of paracrine factors—including anti-inflammatory cytokines and growth factors—that reduce lung inflammation, protect alveolar epithelial and endothelial cells, and enhance the clearance of pulmonary edema. The Phase 2a START trial demonstrated the safety of this approach, though subsequent Phase 2b studies have continued to investigate its efficacy in improving clinical outcomes like ventilator-free days.
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