iPS Cell Products for Parkinson’s, Heart Disease OK’d for Commercialization by Japan Health Ministry Panel

The Yomiuri Shimbun

17:24 JST, February 20, 2026

A health ministry expert panel has approved the commercialization of two regenerative medicine products derived from induced pluripotent stem cells, apparently the first products of their kind in the world.

The panel of the Health, Labor and Welfare Ministry’s Pharmaceutical Affairs and Food Sanitation Council on Thursday gave its green light to the manufacture and sale of the products to treat heart disease and Parkinson’s disease, with certain conditions and time limits attached.

The rollout of the products is believed to be an unprecedented achievement in the clinical application of the technology since Kyoto University Prof. Shinya Yamanaka reported the successful creation of iPS cells in 2006, according to the ministry.

iPS cells can transform into various cell types and are created by introducing several genes into cells, such as those from the skin or blood.

The two products are a cardiomyocyte (heart muscle cell) patch developed by Cuorips Inc., a startup out of Osaka University, and Amchepry, nerve cells for treating Parkinson’s disease developed by major pharmaceutical firm Sumitomo Pharma Co.

The health minister is expected to formally approve both products in the near future.

The cardiomyocyte patch is used for patients with severe heart failure caused by ischemic cardiomyopathy, a condition where the heart’s function deteriorates due to factors such as arteriosclerosis — hardening of the arteries — or myocardial infarctions (heart attacks). The estimated number of patients on whom the treatment might be used in Japan is 3,000.

In the procedure, heart muscle cells generated from iPS cells are processed into patches, three of which are then attached to the patient’s heart.

The expert panel recognized that exercise function indicators improved in four of the eight participants in clinical trials conducted by Osaka University.

Amchepry will be used in the treatment of Parkinson’s disease, which is caused by a decline in brain neurons that produce dopamine — a chemical that helps regulate movement. There are an estimated 250,000 Parkinson’s disease patients in the nation suffering from motor impairments such as tremors and difficulty walking.

Amchepry consists of nerve cells created from iPS cells, which are transplanted into a patient’s brain to improve motor function.

Clinical trials at Kyoto University, which partnered with Sumitomo Pharma for the development, tested the treatment on six individuals. The transplanted cells were found to produce dopamine in every participant, and four of them experienced a clinical improvement in their symptoms.

Future discussions will focus on pricing and insurance eligibility. The costs of the products are expected to be high due to the specialized nature of regenerative medicine.

The approval is conditional, requiring companies to collect data on safety and efficacy after the products are put on the market and seek approval again. Both firms aim to apply for full approval within a seven-year time limit.

“I am very happy to have taken a major step forward at this 20-year milestone since the debut of iPS cells,” Yamanaka said in a statement. “However, to establish this as a medical treatment, a process to confirm safety and efficacy in more cases is essential.”