Japan performs first clinical use of iPS cell heart patch

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A woman in her 50s from Kanagawa Prefecture received the first clinical application of an iPS cell-derived heart patch on September 29 at a clinic in Osaka. The roughly 50-minute procedure used RiHEART, a thin sheet of reprogrammed stem cell-derived heart muscle cells, to treat severe heart failure after a heart attack. The therapy had previously been tested in clinical trials at Osaka University in 2020, but this marks its first use outside a trial setting.
Key Facts
- The procedure took place on September 29 at a clinic in Osaka and lasted approximately 50 minutes.
- The patient is a woman in her 50s from Kanagawa Prefecture suffering from severe heart failure after a heart attack.
- RiHEART is a thin sheet of heart muscle cells grown from iPS cells, which are stem cells obtained by reprogramming ordinary human cells.
- In 2020, Osaka University applied iPS cell-derived heart muscle sheets to patients in a clinical trial.
- RiHEART has received conditional and time-limited approval in Japan, and data on its effectiveness is still being collected.
The Procedure
The operation was performed on September 29 at a clinic in Osaka and lasted about 50 minutes. The patient, a woman in her 50s from Kanagawa Prefecture, suffered from severe heart failure following a heart attack. The treatment involved placing a thin sheet of heart muscle cells directly onto the surface of the heart. The goal is to promote the formation of new blood vessels and support the function of the weakened heart muscle.
RiHEART Technology
RiHEART consists of a thin layer of heart muscle cells grown from iPS cells. iPS cells are stem cells obtained by reprogramming ordinary human cells. The therapy is intended especially for patients suffering from severe ischemic cardiomyopathy. In 2020, Osaka University applied iPS cell-derived heart muscle sheets to patients as part of a clinical trial. This time, the heart patch was used for the first time outside a clinical trial, in ordinary medical practice.
Regulatory Status
RiHEART has received conditional and time-limited approval in Japan. Data collection on the drug's effectiveness is ongoing.