Japan has approved ground-breaking stem cell treatments for Parkinson’s and severe heart failure, one of the manufacturers and media reports said yesterday, with the therapies expected to reach patients within months.
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 Ministry of Health, Labor and Welfare also gave the go-ahead to ReHeart, heart muscle sheets developed by Cuorips that could 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 induced pluripotent stem (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,” Japanese Minister of Health, Labor and Welfare Kenichiro Ueno said. “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 Shimbun 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 5 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, the Parkinson’s Foundation said.
Currently available therapies “improve symptoms without slowing or halting the disease progression,” the foundation said.
US President Donald Trump on Wednesday threatened to take action against the EU if it moves forward with European Commission President Ursula von der Leyen’s proposal to make Canada the bloc’s first associate member. “If they do that, if I think it’s at all a hostile act; I will put very serious tariffs or stop trading with Europe on many things,” Trump told reporters en route to an event in North Carolina, calling the proposal “laughable.” “If it’s a good intention, that’s fine. If it’s a bad intention, we’ll put very heavy tariffs on Europe,” he said. Von der Leyen made the proposal
ON THE MOVE: Trump unexpectedly cut short a trip to return to the White House, while the State Department warned Americans to avoid travel to the Middle East The US on Saturday warned that hostilities between Saudi Arabia and Iran-backed Houthis could “escalate rapidly” after a missile attack targeted Riyadh for the first time since the Yemen conflict resumed. US President Donald Trump on Saturday cut short a weekend at Camp David, a secluded presidential complex in rural Maryland, to return unexpectedly to the White House. The White House gave no explanation for the early return, which comes as a new threshold was crossed in the conflict between Saudi Arabia and the Houthis, who control a large part of Yemen and are fighting government forces backed by a coalition led
The US military came close to boarding a Chinese vessel in the Middle East earlier this year based on a flawed intelligence report prepared with the help of artificial intelligence (AI), CNN said on Friday. US intelligence indicated the ship was carrying nuclear weapons-related components, leading US forces to prepare to intercept it, the broadcaster reported, citing four anonymous sources familiar with the incident. However, the operation was called off after officials determined that an AI chatbot used by an analyst had misidentified the material the ship was carrying. The report was “entirely false,” but “almost started a war,” CNN quoted one source
World leaders gather in New York this week for the UN General Assembly, bracing for US President Donald Trump’s return to the rostrum for a second year running, with talks centering on the widening conflicts in the Middle East and Ukraine and the risks of artificial intelligence (AI). Nearly 130 heads of state meet with the post-World War II order under strain and with the UN itself struggling to remain relevant and weathering attacks from Trump, who has slashed the US’ contributions and withdrawn from dozens of UN bodies. Chinese President Xi Jinping (習近平), who last addressed the diplomatic jamboree via video
RSS