Japan approves stem-cell treatment for Parkinson’s in world first
Pharmaceutical company Sumitomo Pharma said it has received the green light for the production and sale of Amchepry, a treatment for Parkinson’s disease and a stem cell transplant into the patient’s brain.
According to media reports, Japan’s health ministry has also given the green light to ReHeart, heart muscle layers developed by medical startup Cuorips that can help create new blood vessels and improve heart function.
Reports citing the health ministry said the treatments could be launched and offered to patients as early as this summer, making them the world’s first commercially available medical products using (iPS) cells.
Japanese scientist Shinya Yamanaka won the Nobel Prize in 2012 for his research on iPS, which has the potential to transform into any cell in the body.
“I hope this will bring relief to patients not only in Japan but all over the world,” health minister Kenichiro Ueno said at a news conference.
Sumitomo Pharma said in a statement that it had received “conditional and time-limited approval” for the production and marketing of Amchepry under a system reportedly designed to deliver it to patients as quickly as possible.
The Asahi newspaper said the approval was a form of “provisional licence” after the treatment’s safety and effectiveness were assessed based on data from a smaller number of patients than in usual clinical trials for drugs.
A trial conducted by Kyoto University researchers showed that the company’s treatment was safe and successful in improving symptoms.
The study included seven Parkinson’s patients aged 50 to 69; Each was implanted with a total of five million or 10 million cells on both sides of the brain.
iPS cells from healthy donors were transformed into precursors of dopamine-producing brain cells that are no longer found in people with Parkinson’s disease.
It was stated in the study that the patients were followed for two years and there were no significant side effects. Improvement in symptoms was seen in four patients.
Parkinson’s disease is a chronic, degenerative neurological disease that affects the body’s motor system, often causing tremors and other difficulties with movement.
According to the Parkinson’s Foundation, approximately 10 million people worldwide have the disease.
The foundation says currently available treatments “improve symptoms without slowing or stopping the progression of the disease.”
iPS cells are formed by stimulating mature, already specialized cells back to a youthful state; Basically, cloning is done without the need for an embryo.
Cells can be transformed into a number of different cell types, and their use is an important sector of medical research.
