Japan Performs First Surgery Using Commercial iPS Cardiac Muscle Sheets

Overview

• Surgeons at Hospital Osaka Keisatsu implanted three sheets of cardiomyocytes derived from induced pluripotent stem cells into a 50-year-old woman with severe heart failure during a roughly one-hour operation.
• The procedure, which took place on Tuesday, Sept. 29, is the first clinical use of the commercially produced product developed by the University of Osaka and Cuorips and reported as RiHEART.
• Japan granted conditional approval for the therapy in March, allowing limited clinical use while regulators require ongoing data collection and patient follow-up to judge safety and effectiveness.
• Earlier small tests in eight patients with ischemic heart disease were reported to reduce symptoms in all eight and improve cardiac function in four, but those results come from limited samples and local media reports.
• Clinicians will monitor the recent patient for outcomes and safety over time and add more treated cases to determine whether the technique can reduce the need for heart transplants and who may benefit most.