Japan Approves Pioneering Stem-cell Treatments For Parkinson’s, Heart Failure

Japan has approved two pioneering stem-cell therapies for the treatment of Parkinson’s disease and severe heart failure, marking a major milestone in regenerative medicine. The therapies are expected to reach patients within months, according to manufacturers and media reports.

Pharmaceutical company Sumitomo Pharma said it received approval to manufacture and sell Amchepry, a treatment for Parkinson’s disease that works by transplanting stem cells into a patient’s brain.

Japan’s health ministry also approved ReHeart, a therapy developed by medical startup Cuorips to treat severe heart failure. The treatment uses sheets of heart muscle cells that can help form new blood vessels and improve heart function.

Reports say the therapies could be rolled out as early as this summer, potentially making them the world’s first commercially available medical products using induced pluripotent stem cells (iPS cells).

The technology was pioneered by Japanese scientist Shinya Yamanaka, who won the Nobel Prize in Physiology or Medicine in 2012 for discovering how mature cells can be reprogrammed into iPS cells capable of developing into different types of body cells.

Japan’s health minister Kenichiro Ueno said he hoped the breakthrough would bring relief to patients worldwide and that authorities would ensure the treatments reach those who need them.

Sumitomo Pharma said Amchepry received conditional and time-limited approval, a regulatory pathway designed to speed up access to innovative treatments.

A clinical trial led by researchers at Kyoto University involved seven Parkinson’s patients aged between 50 and 69 who received stem-cell-derived dopamine precursor cells implanted into both sides of the brain.

The patients were monitored for two years, during which no major adverse effects were reported, while four participants showed improvements in their symptoms.

According to the Parkinson’s Foundation, about 10 million people worldwide live with Parkinson’s disease, a progressive neurological disorder that affects movement and currently has no cure.