Japan has approved ground-breaking stem cell treatments for Parkinson’s and severe heart failure, one of the manufacturers and media reports said yesterday, with the therapies expected to reach patients within months.
Sumitomo Pharma said it received the green light for the manufacture and sale of Amchepry, its Parkinson’s disease treatment that transplants stem cells into a patient’s brain.
Japan’s Ministry of Health, Labor and Welfare also gave the go-ahead to ReHeart, heart muscle sheets developed by Cuorips that could help form new blood vessels and restore heart function, media reports said.
The treatments could be on the market and rolled out to patients as early as this summer, reports said, citing the health ministry, becoming the world’s first commercially available medical products using induced pluripotent stem (iPS) cells.
Japanese scientist Shinya Yamanaka won the Nobel Prize in 2012 for his research into iPS, which have the potential to develop into any cell in the body.
“I hope this will bring relief to patients not only in Japan but around the world,” Japanese Minister of Health, Labor and Welfare Kenichiro Ueno said. “We will promptly carry out all necessary procedures to ensure it reaches all patients without fail.”
In a statement, Sumitomo Pharma said it had obtained “conditional and time-limited approval” for the manufacture and marketing of Amchepry under a system which is reportedly designed to get these products to patients as quickly as possible.
The approval is a kind of “provisional license,” the Asahi Shimbun said, after the safety and efficacy of the treatment was judged based on data from fewer patients than in ordinary clinical trials for drugs.
A trial led by Kyoto University researchers indicated that the company’s treatment was safe and successful in improving symptoms.
The study involved seven Parkinson’s patients aged between 50 and 69, with each receiving a total of either 5 million or 10 million cells implanted on both sides of the brain. The iPS cells from healthy donors were developed into the precursors of dopamine-producing brain cells, which are no longer present in people with Parkinson’s disease.
The patients were monitored for two years and no major adverse effects were found, the study said.
Four patients showed improvements in symptoms.
Parkinson’s disease is a chronic, degenerative neurological disorder that affects the body’s motor system, often causing shaking and other difficulties in movement.
Worldwide, about 10 million people have the illness, the Parkinson’s Foundation said.
Currently available therapies “improve symptoms without slowing or halting the disease progression,” the foundation said.
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