The single-arm, nonrandomized phase IB study (MSC-COV-10) investigated the safety and preliminary efficacy of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC) in treating COVID-19-induced acute respiratory failure or acute respiratory distress syndrome. COVI-MSCs were administered every other day for up to three infusions and a total of 1,000,000 cells/kg. Patients were followed for 28 days after the final infusion, and no infusion-related adverse events were observed, according to the company.
A pivotal placebo-controlled study is now being planned at multiple sites in the U.S. and Brazil to support an emergency use authorization submission, Sorrento said.
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