A stem cell therapy developed by the biotech company Nature Cell and the Biostar Stem Cell Research Institute, both based in South Korea, has been formally approved in Japan and is now available there to treat mild-to-moderate Alzheimer’s disease patients.
This is the first time ever that a stem cell therapy for Alzheimer’s has been given regulatory approval and made available commercially.
The therapy has available since April 12 at the Japanese hospital Trinity Clinic Fukuoka. The therapy has already been applied to three Korean patients, each administered intravenously with 200 million cells, and there are about 80 patients booked for the treatment through the end of April.
The procedure, which lasts two hours, is administered every two weeks for a total of 10 treatments.
The Kyushu Certified Special Committee for Regenerative Medicine approved the stem cell therapy procedure based on its safety and effectiveness studies.
Nature Cell has an ongoing placebo-controlled Phase 1/2 clinical trial (NCT03117738) evaluating the safety and efficacy of autologous adipose tissue-derived mesenchymal stem cells in Alzheimer’s patients. The company expects to enroll 60 patients to evaluate the number of therapy-related adverse events and assess patients’ cognition from baseline (before the first treatment) to week 32.
The stem cells are extracted from patients’ own (autologous) fat, or adipose, tissue. Following extraction, the cells are expanded in the laboratory until they reach high numbers, and injected back into patients’ blood.
The hopes for stem cell therapy in Alzheimer’s disease are high. Investigators believe the therapy may result in a cure for the disease, compared to existing treatments that merely slow the progression of Alzheimer’s disease.
“It is a great honor to become the first medical institute to use stem cell technology in treating Alzheimer’s patients. Reservations for around 80 patients have already been received for treatment until May, and additional inquiries are steadily being received about reservations for the therapy,” Chang-hee Yang, CEO of Trinity Clinic Fukuoka, said in a press release.
Dr. Jeong-Chan Ra, who, with his team at the Biostar Stem Cell Research Institute, developed the stem cell treatment, said this is the first step in their project to conquer the neurodevelopmental disease.
“With the start of stem cell treatment, Biostar will support Alzheimer’s patients from all over the world – including Japan, Korea, China, and the U.S., starting in Japan – to restore their memory and ultimately their humanity,” he said.