Overview
- An expert panel of the Health, Labor and Welfare Ministry endorsed limited commercialization, with the health minister expected to decide on final approvals soon.
- The products are RiHeart, a heart‑muscle sheet from Cuorips/Osaka University, and Amchepry, dopaminergic neurons from Sumitomo Pharma developed with Kyoto University, which media report would be the first iPS‑based therapies on the market globally if approved.
- Osaka University’s trial of RiHeart in eight severe ischemic cardiomyopathy patients found improved exercise function in four participants.
- Kyoto University Hospital’s Parkinson’s study transplanted about 5–10 million cells into six patients, detected dopamine production in all, saw motor improvements in four after two years, and reported no serious side effects.
- Next steps include pricing and insurance decisions as high costs are anticipated, alongside mandatory collection of real‑world safety and efficacy data for up to seven years.