Japan has approved a groundbreaking stem-cell treatment for Parkinson’s disease, marking the first time such therapy has been cleared for commercial use anywhere in the world.
Pharmaceutical firm Sumitomo Pharma said it received approval to manufacture and sell its treatment called Amchepry, which works by transplanting stem cells into a patient’s brain to help restore lost nerve cell functions.
Japanese authorities also approved a separate therapy for severe heart failure known as ReHeart, developed by medical startup Cuorips, according to media reports.
Both treatments use induced pluripotent stem cells, or Induced Pluripotent Stem Cells, a technology pioneered by Japanese scientist Shinya Yamanaka, who won the Nobel Prize in 2012 for his research.
Japan’s health minister Kenichiro Ueno said the government hopes the innovation will benefit patients beyond Japan.
“I hope this will bring relief to patients not only in Japan but around the world,” Ueno said during a press conference.
Sumitomo Pharma said the treatment received “conditional and time-limited approval,” a regulatory framework designed to accelerate the availability of promising regenerative medicine therapies.
Under the system, treatments can be introduced earlier once initial safety and effectiveness are demonstrated, even if the patient sample in clinical trials is smaller than typical drug studies.
A clinical trial led by researchers from Kyoto University showed encouraging results.
Seven Parkinson’s patients aged between 50 and 69 received stem-cell implants designed to develop into dopamine-producing brain cells — the type of cells that are gradually lost in people with Parkinson’s disease.
The patients were monitored for two years, and researchers reported no major adverse effects. Four participants also showed improvement in their symptoms.
Parkinson’s disease is a chronic neurological disorder that affects movement and motor control. According to the Parkinson’s Foundation, about 10 million people worldwide are living with the condition.
Current treatments primarily focus on managing symptoms rather than slowing the progression of the disease, making stem-cell therapy a potential breakthrough in long-term treatment.