Japanese biotech firm seeks approval for heart cell therapy using iPS cells

ISTANBUL

A Japanese biotechnology company has applied for government approval to produce and sell heart cell sheets developed from induced pluripotent stem (iPS) cells, marking a major step forward in regenerative medicine, Jiji Press reported Wednesday.

Cuorips Inc. submitted the application to Japan’s Health Ministry on Monday, becoming the first company in the country to request approval for a regenerative medicine product based on iPS cell technology.

The therapy, developed under the leadership of Professor Yoshiki Sawa of the University of Osaka—who serves as Cuorips' technology chief—involves transplanting ultra-thin, 0.1-millimeter heart cell sheets measuring 4 to 5 centimeters in diameter. These sheets are created from iPS cells sourced from donors, not the patients themselves.

The first transplant using the technique was conducted in January 2020 on a patient with ischemic cardiomyopathy, a condition in which the heart's ability to pump blood is diminished due to damage caused by restricted blood flow. According to Japan’s National Institute of Health, ischemia leads to the death of heart muscle cells, often resulting in chronic heart failure.

By March 2023, Sawa’s team had performed the procedure on eight patients, confirming both its safety and noticeable improvements in their symptoms.

Calling the application a “giant step,” Professor Sawa expressed hope that the technology would eventually benefit people around the world. “We will continue working to save lives in every corner of the globe,” he said.