A panel of experts gave the green light for Japan's Ministry of Health, Labour and Welfare (MHLW) to approve the commercialization of two regenerative medical products that use induced pluripotent stem cells.
If approved, the allogeneic iPSC-derived therapies would be the first of their kind globally.
ReHeart is developed by Cuorips, a Tokyo-based regenerative medicine company spun out of research at Osaka University. Utilizing myocardial cells derived from human iPS cells, the cardiomyocyte patches are designed to be transplanted on the surface of the heart for the treatment of severe heart failure due to ischemic cardiomyopathy. This therapy aims to support the heart’s overall performance by inducing angiogenesis (the formation of new blood vessels) and facilitating the repair of damaged cardiac tissue. It has been tested in eight people.
The second therapy, Amchepry, is developed by Osaka-based Sumitomo Pharma in collaboration with Tokyo-based Racthera. Amchepry consists of allogeneic iPS cell-derived dopaminergic neural progenitor cells, transplanted into the brains of people with Parkinson’s disease for the improvement of motor functions during the off-time period of patients with advanced disease. It was tested in a small phase 1/2 trial.
The panel examined the therapies under Japan’s conditional approval system; if approved, additional data will be collected for up to seven years. The panel decision represents a huge step forward for regenerative medicine, as the therapeutic potential of iPSC-derived cell and gene therapy products is enormous, but commercial advancement and broad patient access have remained elusive.
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