Japan startup to seek approval for iPS cell therapy in global first

A Japanese startup is poised to become the first in the world to seek government approval for a therapy derived from human induced pluripotent stem (iPS) cells, Nikkei has learned, with a less invasive alternative for treating heart disease, Report informs.

Osaka University-affiliated Cuorips has developed a cardiac tissue sheet using iPS cells, which can be grafted onto the hearts of patients suffering from coronary artery disease. It plans to file an application to make and sell these sheets with Japan's Ministry of Health, Labor and Welfare as early as June.

All eight patients who received the therapy in a clinical trial have seen positive results, with at least one reporting major improvements in their cardiac function.

Patients with severe coronary artery disease currently require either a heart transplant or a ventricular assist device, which pumps blood through the body in place of a heart. Cardiac tissue sheets are much less invasive, since they can be placed through endoscopic surgery.

Heart disease is the second most common cause of death in Japan. Coronary artery disease is said to account for around 30% of those cases.

Japan was estimated to have about 720,000 coronary artery disease patients as of 2020. Globally, the figure likely surpasses 240 million, according to the Global Burden of Disease report.

In a bid to promote regenerative medicine, the Japanese government in 2014 began granting conditional approval to treatments following limited clinical trials. Cuorips plans to take advantage of this framework.

"We aim to receive conditional approval in 2025," said Cuorips President and CEO Takayuki Kusanagi.