Japan OKs World's 1st iPS Cell-Based Products
Japan's health ministry said Friday (March 6) it has conditionally approved the production and sales of two regenerative medical products using induced pluripotent stem cells.
The approval was given to Tokyo-based startup Cuorips Inc.'s cardiac muscle cell sheet called "ReHeart" and Osaka-based drugmaker Sumitomo Pharma Co.'s "Amchepry" dopaminergic nerve cells.
They will mark the world's first practical use of iPS cell-derived medical products.
The products will be covered by the country's public health insurance after the companies file respective applications for the insurance coverage with the ministry.
To obtain full approval, however, Cuorips, a spinout from the University of Osaka, and Sumitomo Pharma have to gather more clinical data including on efficacy over the next seven years and submit them to the ministry for screening, with the target number of ischemic cardiomyopathy patients to be treated with ReHeart set at 75 and that of Parkinson's disease patients to take the Amchepry therapy set at 35.
According to Cuorips, a 4- to 5-centimetre-diameter, 0.1-millimetre-thick ReHeart patch with heart muscle cells made from iPS cells, which can develop into almost all tissues, will restore cardiac function after being applied to a patient's heart.
The startup plans to sell the product in Japan around this autumn and accelerate its efforts to expand overseas.
Sumitomo Pharma said that 5 million to 10 million Amchepry dopaminergic neural progenitor cells derived from iPS cells will be transplanted into the brain centre to improve motor functions.
It plans to conduct post-marketing clinical trials at seven facilities and expects the first transplant to be conducted between October and December this year. Progress over the next two years from the first attempt will be verified to examine its effectiveness and safety.
"We have a sense of tension, believing this is a new start," Sumitomo Pharma President and CEO Toru Kimura told a news conference in the western Japan city of Osaka.
"This is a major milestone for the practical application of iPS cell technology from Japan," he also said, while adding that challenges await the company.
In February, a ministry expert panel proposed that the ministry give conditional, time-limited approval to the two products ahead of full permission, which will take time.
At a press conference on Friday, health minister Kenichiro Ueno said he hopes that the products will save patients around the world.
[Copyright The Jiji Press, Ltd.]
