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First-of-a-Kind Stem Cell Therapies Set for Approval in Japan

Japan’s health ministry is set to grant conditional approval to two first‑of‑a‑kind regenerative medicines – Amchepry for Parkinson’s disease and ReHeart for severe heart failure – after tiny phase I/II trials involving seven and eight patients respectively. Both drugs are derived from reprogrammed induced pluripotent stem cells and showed no serious safety signals, with a few patients reporting symptom relief. Critics argue the data are too limited, lacking control groups, and warn the move is a risky regulatory experiment. The approval would allow a seven‑year, time‑limited market while post‑marketing data are collected.