A Japanese hospital on Tuesday conducted surgery to treat severe heart failure using a cardiac muscle sheet derived from induced pluripotent stem cells, making it the first such case since the regenerative therapy was allowed to be covered by public health insurance.
The procedure involving the iPS cell-derived cardiomyocyte patches called RiHeart finished "smoothly" at a hospital in Osaka, Cuorips Inc., the startup originating from the University of Osaka that developed the product, said. The patient is a female in her 50s from Kanagawa Prefecture, according to the company and hospital.
The operation, carried out by Yoshiki Sawa, professor emeritus at the University of Osaka and president of Osaka Keisatsu Hospital, lasted for about 50 minutes from about 11:15 a.m.
The patient, who is currently in a stable condition, is expected to be discharged in about two weeks to one month.
The treatment is priced at 53.2 million yen ($340,000) per patient and is eligible to those who have not seen their condition sufficiently improve through existing therapies. Japan's high-cost medical expense benefit system caps patients' out-of-pocket payments when medical bills become too expensive.
RiHeart was developed to treat patients with severe heart failure stemming from ischemic cardiomyopathy, a condition in which blocked blood vessels make it difficult for blood to reach the heart.
Culturing cardiac muscle cells derived from donor iPS cells into a sheet and attaching it to the surface of the heart promotes new blood vessel formation and helps restore cardiac function.
In clinical trials, all eight treated patients saw an easing of their symptoms such as fatigue and palpitations, with improvements also observed in heart function and exercise capacity, according to the Ministry of Health, Labor and Welfare.
The commercialization of RiHeart was conditionally approved in March and public health insurance coverage was allowed from Sept. 1.
RiHeart needs to prove its efficacy by 2033 through its treatment of patients to earn a full-fledged approval, with the company aiming to operate on 75 patients.
Generated by Japanese Nobel Prize-winning scientist Shinya Yamanaka of Kyoto University, iPS cells possess the ability to differentiate into almost any human cell type and proliferate virtually indefinitely.
