Japan approves first iPS stem cell therapies for Parkinson's and heart failure
Mar 10th 2026
Japan has approved two iPS cell therapies, Amchepry for Parkinson's and ReHeart for severe heart failure, granting conditional commercial authorizations after limited clinical studies and paving the way for patient rollout potentially this summer.
- Japan granted conditional, time-limited approval for Sumitomo Pharma's Amchepry and Cuorips' ReHeart, allowing manufacture and sale as the first commercial iPS cell medical products.
- Amchepry transplants donor-derived iPS cell precursors to replace dopamine-producing brain cells lost in Parkinson's disease.
- A Kyoto University-led trial of seven Parkinson's patients reported no major adverse events over two years and symptom improvement in four patients.
- ReHeart uses engineered heart muscle sheets to help form new blood vessels and restore heart function in severe heart failure.
- Regulators based approval on smaller-than-usual clinical data under a provisional system and say the therapies could reach patients as early as this summer.