The Japanese Ministry of Health has given the green light for the commercial use of unique regenerative medicine products based on induced pluripotent stem cells (iPS). These drugs are intended for the treatment of severe forms of heart failure and Parkinson's disease, as reported by Kazinform citing SCMP.
The approval concerns two drugs: ReHeart, which is used for the therapy of ischemic cardiomyopathy, and Amchepry, designed to correct degenerative changes caused by Parkinson's disease.
Shinya Yamanaka, a Nobel Prize laureate and honorary director of the iPS Cell Center at Kyoto University, expressed joy over this achievement, noting that it is the first significant step towards the practical application of a technology developed two decades ago.
The method used in the ReHeart drug involves cardiomyocytes derived from iPS cells. These cells form patches that are applied to the patient's heart, promoting angiogenesis and restoring its functions. Clinical trials show a reduction in shortness of breath and an improvement in physical endurance in patients.
As for Amchepry, it involves the injection of neuronal precursor cells into the brain, which begin to produce dopamine. In the trials, six out of seven patients showed partial restoration of motor functions.
It is worth noting that the approval from the Ministry of Health is limited and is valid for seven years. The drugs are permitted for use only in small clinical groups, and widespread implementation will only be possible after confirming their safety and efficacy within the established timeframe.
Sales of these products are expected to begin by the end of this year, after pricing is finalized and the drugs are included in the medical insurance system. The company Cuorips plans to start marketing its products this year.
