Japan startup applies for approval of iPS cell therapy for heart disease
Clinical trials involving eight patients showed improvements in symptoms and cardiac function.
Cuorips announced it has submitted an application to Japan’s health ministry for approval to produce and sell sheets of heart muscle cells derived from induced pluripotent stem cells (iPS cells), intended as a treatment for heart disease.
Cuorips, a startup established at Osaka University, has collaborated closely with the university to develop cardiomyocyte sheets—thin, processed sheets approximately 0.1 millimeters thick that contain heart muscle cells generated from iPS cells (cells reprogrammed from adult cells into a pluripotent state capable of becoming multiple cell types).
The firm reports they’ve conducted clinical trials transplanting these sheet into the hearts of eight patients with severe heart disease. According to the company, all patients experienced reductions in symptoms such as fatigue and palpitations, and clinical indicators of cardiac function improved in more than half of the patients. Additionally, the company indicates that no serious side effects were observed in these trials.
Since Professor Shinya Yamanaka of Kyoto University first announced the successful creation of iPS cells in 2006, clinical studies involving transplantation of iPS-derived cells have been conducted in various parts of the world, including the United States and China.
Cuorips states that, if their product receives approval from Japanese regulatory authorities, it will likely become the first authorized therapeutic application of iPS cells in the world. Japanese health authorities are expected to evaluate the therapy’s safety and effectiveness based on the provided clinical trial data and additional supporting information.
Professor Yoshiki Sawa of Osaka University, who leads the development team, commented on the process: “There have been countless hurdles to be cleared to prove that treatment using iPS cells, which no one has ever done, is safe and effective.”
He further stated, “Getting domestic approval will be the first step toward making it widespread,” adding, “I will work hard to gather data, as it is important to show its efficacy even after it is approved.”
