Japan approves 1st iPS stem cell therapies for heart failure, Parkinson’s
EL.KZ Информационно-познавательный портал
Japan has conditionally approved the world’s first commercial regenerative medicine treatments developed from induced pluripotent stem (iPS) cells, a major milestone in advanced medical research, El.kz cites Anadolu.
The decision allows the limited use of two therapies: ReHeart, developed by Cuorips Inc. to treat severe heart failure caused by ischemic cardiomyopathy, and Amchepry, created by Sumitomo Pharma Co. and Racthera Inc. to treat Parkinson’s disease, according to Kyodo News.
“I hope they will save patients not only in Japan but also all around the world,” said Health, Labor and Welfare Minister Kenichiro Ueno.
The treatments could begin reaching patients as early as this summer, though final pricing and national insurance coverage are still under discussion. ReHeart is expected to cost more than 10 million yen (about $63,500), while Amchepry is also expected to carry a high price.
The approvals were granted under a special framework that allows early conditional use of innovative medicines once safety is confirmed and potential effectiveness is demonstrated, even with limited clinical trial data. Developers must prove the therapies’ effectiveness within seven years to secure full approval.
iPS cells can transform into nearly any type of human cell and can multiply indefinitely, making them a powerful tool for regenerative medicine. The technology was pioneered by Japanese scientist Shinya Yamanaka, who won the 2012 Nobel Prize in Physiology or Medicine for his discovery.
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