The Japanese Ministry of Health has given the green light for the commercial use of the world's first medications based on induced pluripotent stem cells (iPS) for the treatment of severe forms of heart failure and Parkinson's disease, reports Kazinform citing SCMP.
The approved drugs include ReHeart, intended for the therapy of ischemic cardiomyopathy, and Amchepry, which is used for treating degenerative changes in Parkinson's disease.
Shinya Yamanaka, Nobel Prize laureate and honorary director of the iPS Cell Center at Kyoto University, expressed his satisfaction: "This is a significant step towards the practical application of the technology, 20 years after its discovery."
The ReHeart drug is based on cardiomyocytes derived from iPS cells. These cells form patches that are applied to the patient's heart, promoting angiogenesis and restoring organ function. Clinical trials showed that patients reported a decrease in shortness of breath and improved physical endurance.
As for Amchepry, it involves the introduction of precursor cells into the brain that begin to produce dopamine. During the trials, six out of seven participants experienced partial restoration of motor functions.
The Ministry's approval has a limited duration of seven years. The drugs can only be used within small clinical groups. Full implementation into practice will be possible after confirming their safety and efficacy during this period.
Sales of the products are expected to begin by the end of this year, after the pricing procedures and inclusion of the drugs in the health insurance system are completed. Cuorips has already announced its intentions to launch sales this year.
