Japan becomes first country to approve stem-cell therapies for Parkinson’s disease and severe heart failure.

Key facts

• Japan’s health ministry granted manufacturing and marketing approval to Amchepry, Sumitomo Pharma’s iPS cell-based therapy for Parkinson’s disease.
• The ministry also approved ReHeart, heart muscle sheets developed by medical startup Cuorips, to restore heart function in severe heart failure patients.
• Both products are expected to reach patients as early as summer 2026, making them the world’s first commercially available treatments using induced pluripotent stem (iPS) cells.
• Amchepry received conditional and time-limited approval under Japan’s fast-track system that relies on smaller patient datasets than standard drug trials.
• A Kyoto University-led trial of Amchepry involved seven Parkinson’s patients aged 50-69 who received five million or ten million iPS-derived dopamine precursor cells implanted bilaterally in the brain.
• During the two-year follow-up no major adverse effects were reported and four of the seven patients showed symptomatic improvement.