Japan has approved pioneering stem cell therapies for Parkinson’s disease and severe heart failure, with patient availability expected in a few months, according to company and media reports on Friday (6).
Sumitomo Pharma confirmed authorization to manufacture and sell Amchepry, its stem-cell-based Parkinson’s treatment.
Approval of ReHeart for Heart Regeneration by Cuorips
The Japanese Ministry of Health approved ReHeart, heart muscle sheets by Cuorips to enhance blood vessel growth and heart function, according to news outlets.
The Ministry of Health indicated that these therapies could become available to patients by mid-year.
If approved, the Parkinson’s treatment would be the first commercial medical product worldwide to utilize induced pluripotent stem cells (iPS), which scientists generate by reprogramming mature adult cells back into a youthful, versatile state.
Researchers can convert iPS cells into many different cell types, making them a major focus of ongoing medical research.
Nobel Prize Recognition for Shinya Yamanaka’s iPS Cell Research
Japanese scientist Shinya Yamanaka received the Nobel Prize in 2012 for his work on iPS cells.
“At a press conference, Health Minister Kenichiro Ueno expressed hope that the treatment would provide relief not just in Japan, but globally.”
Sumitomo Pharma stated that it had secured “conditional and time-limited approval” to manufacture and sell Amchepry.
A study by researchers at Kyoto University found that the company’s treatment was both safe and effective in alleviating symptoms.
iPS Cell Implants for Parkinson’s Patients
The trial involved seven Parkinson’s patients aged 50 to 69, each receiving five to ten million cells implanted on both sides of the brain.
iPS cells from healthy donors were developed into precursors of dopamine-producing neurons, which are depleted in Parkinson’s disease.
This progressive neurological disorder primarily affects the motor system, often leading to tremors and other movement difficulties.
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