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Japan approves world’s first regenerative medicines using iPS cells

Drugs made with iPS, or induced pluripotent stem cells, will be used to treat patients with severe heart failure and Parkinson’s disease

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A heart muscle sheet derived from human stem cells at the University of Osaka. Photo: Kyodo
Kyodo
Japan’s health ministry panel on Thursday approved the commercialisation of two regenerative medicine products prepared from iPS cells, the first of their kind in the world.

The two drugs, ReHeart developed by Cuorips, a start-up originating from the University of Osaka, and Amchepry by Sumitomo Pharma and Racthera, will be used for patients with severe heart failure stemming from ischemic cardiomyopathy and Parkinson’s disease, respectively.

“I am very happy to see the first big step towards its societal implementation, 20 years since it was announced,” said Shinya Yamanaka, director emeritus at Kyoto University’s Centre for iPS Cell Research and Application.
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Induced pluripotent stem cells, or iPS, were generated by Yamanaka, who announced the generation of mouse iPS cells in 2006 and human iPS cells in 2007. He won the Nobel Prize in Physiology or Medicine in 2012.

With ReHeart, heart muscle sheets derived from human iPS cells are placed on the surface of the heart, where they promote the formation of new blood vessels underneath and help restore heart function.

Shinya Yamanaka announced the generation of human iPS in 2007. Photo: Wikipedia Commons
Shinya Yamanaka announced the generation of human iPS in 2007. Photo: Wikipedia Commons

Patients with severe heart disease are often given medicine to prevent deterioration and sometimes may have to undergo a heart transplant.

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