The Phase 2 study will assess the safety and efficacy of Longeveron's stem cell treatment under Japan's accelerated regulatory pathway for regenerative medicine. MIAMI, June 1, 2020 /PRNewswire/ --Longeveron LLC announced today that Japan's Pharmaceutical and Medical Devices Agency (PMDA) (the Japanese agency akin to the United States' Food & Drug Administration) approved a Clinical Trial Notification (CTN) application (akin to an Investigational New Drug Application or "IND" in the US regulatory system), approving the initiation of a Phase 2 clinical trial evaluating the safety and efficacy of Longeveron's Mesenchymal Stem Cells (LMSCs) for the treatment of Aging Frailty in Japanese patients.
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