Japan has approved ground-breaking stem-cell treatments for Parkinson's and severe heart failure, one of the manufacturers and media reports said Friday, with the therapies expected to reach patients within months.
Pharmaceutical company 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 health ministry also gave the go-ahead to ReHeart, heart muscle sheets developed by medical startup Cuorips that can 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 (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," health minister Kenichiro Ueno told a press conference.
"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 newspaper 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 five 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, according to the Parkinson's Foundation.
Currently available therapies "improve symptoms without slowing or halting the disease progression," the foundation says.
iPS cells are created by stimulating mature, already specialised, cells back into a juvenile state -- basically cloning without the need for an embryo.
The cells can be transformed into a range of different types of cells, and their use is a key sector of medical research.
1009naturelover on March 8th, 2026 at 05:32 UTC »
"At least 1.1 million people in the United States are living with Parkinson’s disease. It’s the second-most-common neurodegenerative disease after Alzheimer’s disease, with estimates that 90,000 people are diagnosed with Parkinson’s disease each year.
Age is the most common risk factor, with the average age of onset around age 60. Understandably, older adults, who are most affected by the disease, are on the lookout for possible signs of the condition. "
At times my hand shakes and once someone asked if I had Parkinson. I am in my early 60s and my doctor said its too early to tell now and that hopefully I do not. I am in good shape, and not overly worried. However, its impossible to totally forget about it.
Hopefully the trials will be successful and help those in real need.
However, it will need to be affordable enough for Blue Cross and Medicare.
unfinishedtoast3 on March 8th, 2026 at 05:30 UTC »
doctor here!
Canada and the US are in Phase one research, but Japan is definitely jumping the gun going to approval for large scale human trials.
the treatment is super invasive and super risky. we basically turn stem cells into neuron progenitors and then implant them into dopamine producing regions in the brain, and hope they kickstart dopamine release. Dopamine insufficiency is believed to be the cause of Parkinson's, so the hope is we can slow down the disease by increasing dopamine production.
its risky for a few reasons. we are only 18 months out from the first human trials, and we're still watching for brain tumors to pop up, which is the most dangerous side effect we can envision. the folks who participated in trials were basically end stage, so the risk was acceptable to them.
we are definitely seeing good things. we are also dont really understand Dopamine, and theorize that Dopamine Psychosis can occur by overstimulating dopamine receptors in the brain, what we believe to be a cause of schizophrenia.
so, the US and Canada want more trials and a few more years of review on existing patients before rolling out large human trials. Japan has decided "Fuck it, lets see what happens."
son_of_Khaos on March 8th, 2026 at 05:13 UTC »
Thank God. It's a horrible disease, and we should do everything in our power to out an end to it. Kudos to Japan.