July 30, 2020 -- Regenerative medical products manufacturer Direct Biologics has won approval from the U.S. Food and Drug Administration to study its ExoFlo therapy in a clinical trial with COVID-19 patients.
ExoFlo is an investigational drug that uses extracellular vesicles derived from bone marrow to help modulate inflammation and potentially stimulate cellular communication. The ExoFlo Infusion Treatment for COVID-19 (EXIT COVID-19) Trial will test the product's ability to improve moderate to severe acute respiratory distress syndrome (ARDS) in 60 patients with the novel coronavirus disease.
The multicenter, double-blind clinical trial is believed to be the first to use bone marrow-derived extracellular vesicles to treat ARDS in COVID-19 patients, the company noted. It will investigate whether ExoFlo alters patients' days to recovery and mortality rates.
The EXIT COVID-19 trial builds upon a previous phase II study on the safety and efficacy of ExoFlo. The first trial enrolled 24 critically ill patients with COVID-19 and produced promising safety and efficacy data, according to Direct Biologics.