The Japanese Ministry of Health has become the first in the world to give the green light for the commercial use of innovative regenerative medicine drugs based on induced pluripotent stem cells (iPS). This was reported by Kazinform, citing SCMP. The drugs ReHeart and Amchepry are intended for the treatment of severe heart failure and Parkinson's disease, respectively.
Shinya Yamanaka, Nobel Prize laureate and honorary director of the iPS Cell Center at Kyoto University, expressed his joy over this event, calling it a significant step in the practical application of the technology that emerged two decades ago.
The ReHeart drug is developing a method based on the use of cardiomyocytes derived from iPS cells. These cells are applied to the patient's heart to stimulate angiogenesis and restore its functions. Clinical trials have shown that patients experience reduced shortness of breath and improved physical endurance.
Amchepry, in turn, is a drug that introduces neuronal precursor cells into the brain, promoting dopamine production. During clinical trials, partial regeneration of motor functions was noted in six out of seven participants.
However, the approval issued by the Ministry of Health has a limited validity period of seven years. The drugs can be used within the framework of small clinical studies, and full implementation will only be possible after confirming their safety and efficacy within the specified period.
Sales of the new medications are expected to start by the end of this year, after the pricing processes are completed and they are included in the health insurance system. The company Cuorips has announced its intentions to begin sales this year.
