Japan Approves First iPS Cell–Based Regenerative Therapies for Heart and Parkinson’s
Japan’s health ministry granted conditional, time‑limited approvals to two regenerative medicines derived from donor iPS cells—ReHeart for severe heart failure and Amusepri for Parkinson’s—marking the world’s first market authorizations for iPS‑cell–based therapies. Developed with Kyoto University and Osaka University collaborators, the products will be produced at the SMaRT facility in Suita and require post‑marketing safety and efficacy studies; insurance coverage will follow after regulatory steps. This milestone, tied to the 20th anniversary of mouse iPS cell creation, highlights Japan’s leadership in translating reprogrammed cells into clinical practice.