“Twenty years after they were first created in Japan, extraordinarily versatile stem cells made from the body’s own cells may finally realize their promise for regenerating diseased tissue. Last month, an advisory panel to Japan’s health ministry recommended limited marketing approval for therapies using induced pluripotent stem (iPS) cells for heart failure and Parkinson’s disease. In a controversial arrangement, their makers will be able to sell the products for 7 years while continuing studies to determine just how well the therapies work. IPS cells are moving closer to medical use in other countries as well, with dozens of potential therapies in clinical trials…

One of the new therapies, intended for heart disease patients, was developed by Kyoto University’s Center for iPS Cell Research and Application (CiRA) in collaboration with a University of Osaka group led by cardiovascular surgeon Yoshiki Sawa. Heart muscle cells derived from iPS cells are formed into small patches. Applied to a diseased heart’s surface, the muscle patches boost contraction while also releasing cytokines that promote blood vessel formation.

Eight heart disease patients have received RiHEART patches made by Cuorips, a startup spun off from the university. The company has reported in press briefings and two peer-reviewed papers—in Frontiers in Cardiovascular Medicine in 2022 and 2023—that there were no serious safety issues and patients’ heart function improved.

The Parkinson’s therapy, developed by a group led by neurosurgeon Jun Takahashi, CiRA’s current director, coaxes iPS cells to form replacements for the dopamine-producing neurons that die off in Parkinson’s. In a small pilot trial, surgeons drilled holes into the skulls of six Parkinson’s patients and injected the replacement cells. There were no safety issues, and four of the patients showed improvement 24 months after transplantation, Takahashi and colleagues reported in Nature last year. Sumitomo Pharma and RACTHERA are commercializing the treatment, dubbed Amchepry.”

From Science.