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Japan Panel OKs Medical Products Using iPS Cells
Japan's health ministry panel conditionally approved two iPS cell therapies, requiring up to seven years of data collection to confirm safety and efficacy for heart failure and Parkinson’s patients.
- On Feb 19, 2026, a Japanese health ministry expert panel recommended commercialisation of two regenerative medical products from iPS cells: ReHeart by Cuorips and Amchepry by Sumitomo Pharma and Racthera.
- Shinya Yamanaka's work established induced pluripotent stem cells that can transform into nerve, muscle, and other body cells, earning him the 2012 Nobel Prize.
- Trial data show ReHeart patches, 4 to 5 centimeters diameter and about 0.1 millimeter thick, tested on eight patients by 2023, while Amchepry involved transplants of about 5 million to 10 million neural cells.
- Under the conditional approval system, the panel required developers to study all treated patients and verify safety and efficacy within seven years, while the Japanese health ministry is expected to approve within one to two months.
- Clinical trial records show activity across about 20 diseases in Japan, but experts warn long-term safety remains a key challenge amid global research competition in iPS technology.
13 Articles
13 Articles
iPS Cell Products for Parkinson’s, Heart Disease OK’d for Commercialization by Japan Health Ministry Panel
A health ministry expert panel has cleared the commercialization of two regenerative medicine products derived from induced pluripotent stem cells, apparently the first products of their kind in the world.
Stem cell therapy products capable of treating Parkinson's disease and severe heart failure are set to be commercialized in Japan for the first time in the world. They are expected to be available for specific patients at select hospitals in Japan soon. According to Japanese media outlets on the 20th, two Japanese regenerative medicine products utilizing iPS cells (induced pluripotent stem cells) have passed the review of a committee of experts …
Pending validation, this treatment would be the first to use reprogrammed stem cells A panel of government experts in Japan has granted approval in principle to projects
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