US EditionJapan approves stem-cell treatment for Parkinson's in world first
Japan conditionally approved Amchepry and ReHeart, the first commercial iPS cell therapies, with safety and efficacy monitoring required over seven years.
- On Friday, March 6, 2026, Japan's Health, Labor and Welfare Ministry approved two iPS-cell therapies, including Sumitomo Pharma's Amchepry, for Parkinson's disease.
- IPS cells can transform into many cell types and stem from Nobel laureate Shinya Yamanaka's research, enabling therapies without embryos under provisional licenses requiring seven-year patient surveys.
- A Kyoto University-led trial treated seven Parkinson's patients with five million or 10 million cells implanted per patient, monitoring them for two years with no major adverse effects and four showing symptom improvements.
- Companies aim to start selling between summer and autumn this year, and following national deliberations, pricing and public health insurance coverage will be decided.
- Worldwide about 10 million people have Parkinson's, and Sumitomo Pharma's Amchepry targets Parkinson's while Cuorips Inc.'s ReHeart uses donor iPS cells and cardiomyocyte sheets to treat severe ischemic cardiomyopathy.
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55 Articles
Japan has approved the world's first iPS cell therapy based on Nobel Prize-winning technology. Japan has opened the way for commercialization of regenerative medicine for heart failure and Parkinson's disease. The Japanese government has approved the world's first regenerative medicine treatment using induced pluripotent stem cells (iPS cells). The Japanese Ministry of Health, Labor and Welfare announced on the 6th that it has approved a treatme…
Japan approves stem cell treatments for Parkinson's and heart failure, soon to be available, marking a breakthrough in regenerative medicine
Japan's health ministry approves iPS cell products for first practical use
Japan's health ministry has announced formal approval for the domestic manufacture and sale of two products for the treatment of heart disease and Parkinson's disease using iPS cells. It means such treatments will be put to practical use for the first time in the world.
World's first: Japan approves stem-cell treatment for Parkinson's
TOKYO: Japan has approved ground-breaking stem-cell treatments for Parkinson's and severe heart failure, one of the manufacturers and media reports said Friday, with the therapies expected to reach patients within months.Pharmaceutical...
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