The approvals, granted by Japan’s Ministry of Health, Labour and Welfare, cover two regenerative therapies: ReHeart, developed for severe heart failure, and Amusepri, designed for Parkinson’s disease. Both therapies use adult human cells that have been reprogrammed into a stem-cell-like state capable of differentiating into specialised tissues.  

ReHeart, developed by Osaka University startup Qualipse, uses sheets of cardiomyocytes derived from donor iPS cells that are surgically attached to the surface of the heart. Amusepri uses precursor dopamine-producing neurons derived from iPS cells to treat Parkinson’s disease.  

The approvals remain conditional and time-limited, meaning further post-marketing clinical monitoring will be required to establish long-term safety and efficacy. Researchers described the decision as a significant step towards practical application of regenerative cell therapies, while emphasising that larger-scale clinical validation is still needed.