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This investigational cell therapy consists of allogeneic, bone marrow-derived mesenchymal stromal cells (MSCs) developed by the Masonic Cancer Center at the University of Minnesota. Specifically designed for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) secondary to COVID-19 pneumonia, the therapy is manufactured at the University's Molecular and Cellular Therapeutics (MCT) facility. The MSCs function through complex immunomodulatory mechanisms, targeting the systemic 'cytokine storm' and localized inflammatory response to reduce lung injury. Proposed therapeutic actions include the enhancement of alveolar fluid clearance, regulation of pulmonary vascular endothelial permeability, and the suppression of cellular apoptosis. A Phase 2A randomized, placebo-controlled trial (NCT04333368) evaluated the safety and efficacy of multiple intravenous infusions of these cells, although the study did not demonstrate a statistically significant reduction in 30-day mortality compared to standard care.
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