FDA approves Athersys Inc.’s MultiStem cell therapy for a coronavirus study


The federal government has given Cleveland-based Athersys Inc. (Nasdaq: ATHX) the go-ahead for a clinical trial to test the company’s MultiStem cell therapy in patients with acute respiratory distress syndrome (ARDS) induced by the novel coronavirus.

The biopharmaceutical company said in a news release on Monday, April 13, that the U.S. Food and Drug Administration has authorized it to “initiate a Phase 2/3 pivotal study to assess the safety and efficacy” of MultiStem in patients with “moderate to severe” ARDS resulting from COVID-19. Athersys plans to open the first clinical sites this quarter for recruitment in what it calls the MACOVIA — MultiStem Administration for COVID-19 Induced ARDS — study.

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Story excerpt provided by Crain’s Cleveland Business.

Written by Scott Suttell

Originally published April 13, 2020.

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