On February 19, an expert panel at the Ministry of Health, Labor and Welfare conditionally endorsed the manufacturing and sale of two regenerative medicine products derived from iPS cells under a fast-track system, paving the way for them to become the world’s first iPS cell-based commercial products.

One of the two products is the heart muscle patch RiHEART, developed by Cuorips, a venture company spun out of the University of Osaka.

The cardiac muscle sheets are for heart failure patients and designed to be attached to the heart with the aim of restoring weakened cardiac function.

All eight patients who have undergone the procedure so far experienced improvements in symptoms such as fatigue and palpitations.

The other is drugmaker Sumitomo Pharma’s AMCHEPRY, which consists of early-stage brain cells that can develop into dopamine-producing neurons.

The cells are expected to improve symptoms of Parkinson’s disease, including limb tremors, after they are transplanted into the brain.

Among the six patients who have participated in clinical trials so far, four showed improvements in motor function.

Both products were endorsed subject to multiple conditions, including a seven-year evaluation period to further verify their effectiveness.

Health minister Ueno Kenichiro said on February 20 that he expects to grant formal approval to the products possibly in the early part of March.

After approval, prices will be set for the products, which could be available to patients as early as this summer.

In response to the development, Kyoto University Professor Yamanaka Shinya said he is pleased that a big step has been taken toward real-world application 20 years after he first identified mouse iPS cells.

The 2012 Nobel laureate noted that it is essential to continue confirming safety and effectiveness through many more cases to firmly establish these treatments as standard medicine.

Yamanaka emphasized the importance of maintaining scientific caution and continuing to make progress steadily, one step at a time.