Japan has approved a pioneering stem cell based treatment for Parkinson’s disease, marking the first time such a therapy has been authorized for commercial use anywhere in the world.
The decision allows pharmaceutical company Sumitomo Pharma to manufacture and distribute a treatment designed to transplant stem cells into the brains of patients suffering from the neurological disorder.
The therapy aims to restore cells responsible for producing dopamine, a chemical that plays a key role in controlling movement. In people with Parkinson’s disease, these cells gradually deteriorate, leading to symptoms such as tremors, stiffness and difficulty with movement.
Health authorities also approved a second stem cell therapy designed to treat severe heart failure. The treatment involves placing sheets of heart muscle cells onto damaged heart tissue to encourage the growth of new blood vessels and improve cardiac function.
Both therapies are expected to become available to patients within months.
The Parkinson’s treatment uses induced pluripotent stem cells, often called iPS cells. These cells are created by reprogramming mature human cells so they can develop into many different types of tissue in the body.
The discovery of iPS cells by Japanese scientist Shinya Yamanaka earned the Nobel Prize in 2012 and opened the door to new approaches in regenerative medicine.
Researchers involved in the Parkinson’s treatment say the therapy works by converting stem cells from healthy donors into early stage dopamine producing brain cells. These cells are then implanted into specific areas of the patient’s brain where dopamine production has been lost.
Early clinical trials conducted by researchers at Kyoto University tested the treatment on seven patients between the ages of 50 and 69.
Participants received between five million and ten million transplanted cells in both sides of the brain. Over a two year monitoring period, researchers reported no serious side effects linked to the procedure.
Four of the seven patients showed measurable improvements in their symptoms following the treatment.
Regulators granted the therapy a conditional approval, which allows it to reach patients sooner while further data continues to be collected.
Parkinson’s disease is a long term degenerative disorder that affects the nervous system and the body’s ability to control movement. Around 10 million people worldwide are estimated to be living with the condition.
Existing treatments can help manage symptoms but do not stop the disease from progressing.
Scientists hope stem cell therapies could eventually transform treatment by replacing damaged cells rather than simply managing the symptoms.
Researchers say the approval in Japan could accelerate the development of similar therapies around the world as regenerative medicine continues to advance.
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