Japan performs the world’s first transplant of an iPS-cell-derived heart muscle sheet under standard public health insurance coverage
Japan performs the world’s first transplant of an iPS-cell-derived heart muscle sheet under standard public health insurance coverage
On September 29, 2026, surgeons at Osaka Keisatsu Hospital sutured a RiHeart sheet of heart muscle cells grown from iPS cells onto the heart of a woman in her 50s with severe heart failure. Surgeon Yoshiki Sawa developed the therapy in collaboration with Nobel laureate Shinya Yamanaka, who discovered how to produce iPS cells. This was the first such operation since Japan’s public health insurance began covering the treatment on September 1.
The patient, from Kanagawa Prefecture, had suffered a heart attack that left her heart unable to pump enough blood. Ordinary walking made her breathless, and she had to stop halfway up a flight of stairs. The operation began at 11:15 and lasted about 50 minutes, during which surgeons sutured the RiHeart sheet onto the surface of her heart. Sawa performed the procedure himself. He is the hospital’s president, a professor emeritus at Osaka University, and a director of Cuorips, the company that developed RiHeart. The patient is in stable condition and is expected to leave hospital in two to four weeks.
The RiHeart sheet consists of living heart muscle cells grown from iPS cells. These are ordinary body cells reprogrammed into a state similar to that of embryonic cells, from which almost any tissue can be grown. Once sutured onto the heart, the sheet releases substances that stimulate new blood vessel growth in the damaged area. This vascular network restores blood flow to the heart tissue. The operation took place twenty years after Yamanaka first produced iPS cells, marking the technology’s progression from a laboratory discovery to treatment for a patient.
Approval rests on a small trial. According to Japan’s health ministry, eight patients with ischemic heart disease, a narrowing of the arteries that supply the heart muscle, received the sheets. All experienced relief from fatigue and palpitations, and four also showed improved heart function. A sample this small is insufficient for conventional drug approval. Japan therefore approved RiHeart in March 2026 through a separate pathway for regenerative medicine products that grants conditional, time-limited approval. This pathway allows a cell product to be sold when its effectiveness is still only anticipated, provided the company continues collecting data. To obtain full approval, Cuorips must treat another 75 patients at 20 hospitals in Japan by 2033.
The hospital points to Japan’s shortage of donor hearts as a reason this treatment is needed. Too few heart transplants are available, while about 1,2 million people have chronic heart failure, a number that is rising as the population ages. RiHeart costs 53,2 million yen, or about 340 thousand dollars per patient, making it one of Japan’s most expensive medical products. A health insurance benefit scheme caps patients’ out-of-pocket costs. A second iPS therapy, for Parkinson’s disease, was approved through the same pathway on the same day. At the same press conference, Japan’s health minister, Kenichiro Ueno, pledged to make these treatments available as quickly as possible to all patients in Japan and around the world.
Before the operation, the patient told Asahi Shimbun what she hoped the treatment would allow her to do:
“I want to take my dog for a long walk without having to hold back.”