Biostar Stem Cell Research Institute, jointly operated by Nature Cell and Rbio, announced that Trinity Clinic Fukuoka, a partner hospital in Japan, received approval for the application of regenerative medicine in Alzheimer’s disease and officially began stem cell treatment as of April 12.
Earlier in March, Trinity Clinic Fukuoka received approval from the Kyushu Certified Special Committee for Regenerative Medicine for the safety and effectiveness in applying regenerative medicine to Alzheimer’s patients, based on the Act on the Safety of Regenerative Medicine in Japan. The evaluation results were delivered to the Kyushu branch office of Japan’s Ministry of Health, Labor and Welfare (MHLW), and the treatment was officially approved by the Ministry on April 11.
Trinity Clinic Fukuoka started the first stem cell treatment to three Korean Alzheimer’s patients, who were each administered with 200 million cells over two hours. They will receive treatment every two weeks, for a total of 10 treatments.
The stem cell therapy of Alzheimer's disease is to administer autologous adipose tissue-derived mesenchymal stem cells intravenously. This is a novel approach to treating Alzheimer’s disease, using unique stem cell technologies that have been developed over more than 13 years. The treatment involves a number of patented technologies, such as methods for producing stem cells of a size suitable for intravascular administration, culture medium compositions for regenerating stem cells, and compositions for enhancing storage stability of serum-containing stem cells. Dr. Jeong-Chan Ra has been testing intravenous injections in his own body since 2008 to evaluate the safety of this process. Moreover, the safety of intravenous infusion has been established in clinical trials in the United States. Published clinical studies show that multiple injections are unlikely to cause cancer in humans.
Unlike the existing treatment for Alzheimer’s disease that only slows the progression of the illness, stem cell therapy is expected to be a fundamental cure for the disease. Dr. Ra’s research team tested animals that have Alzheimer's disease and proved the effectiveness of the stem cell treatment of Alzheimer’s disease as well as the prevention of Alzheimer’s disease. Dr. Ra’s study was also published in the international journal Plos-One in 2012, and the treatment is known to perform multiple functions including anti-inflammation, cerebral vascular regeneration, and brain cell protection and regeneration.
Stem cell therapy can be applied to mild-to-moderate Alzheimer’s patients who are aged 65 or older. Patients with early-stage Alzheimer’s disease who are 55 years or older can also receive the stem cell treatment if their family members or guardians agree to the treatment. However, pregnant women and those with serious diabetes or cardiac failure cannot receive the treatment.
“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. “As the world is seeing accelerated growth in aging populations and a drastic increase in Alzheimer’s patients, the need for treating Alzheimer’s patients can be met at Trinity Clinic Fukuoka.”