SEOUL, South Korea--(BUSINESS WIRE)--Biotechnology enterprise Nature Cell (KOSDAQ:007390) announced that it had started to recruit patients for its clinical trials of ‘ASTROSTEM,’ a stem cell drug for Alzheimer's disease treatment, in the U.S.
The phase I and II clinical trials regarding Alzheimer's disease were approved by the U.S. FDA on November 24th, 2016. In February 2017, IRB approval was obtained regarding the clinical trial protocol and on March 8th, 2017, IRB final approval was obtained regarding Syrentis Clinical Research and ATP Clinical for the two hospitals in the U.S. which will act as institutions to conduct the clinical trial, meaning that all of the authorization processes were finalized and the recruitment of patients could finally be started.
Biostar Stem Cell Research Institute (Director: Jeong-chan Ra), which is co-operated by Nature Cell and R Bio, has developed a technology for culturing autologous fat stem cells. The institute has invested more than KRW 300 billion in its research and development efforts over the last 10 years, allowing it to develop stem cell drugs for intractable disease treatments through regeneration of blood vessels, cartilage and neurons.
Biostar institute has already succeeded in its clinical trial regarding Buerger's disease and Romberg's disease. The results of the clinical trials for ‘JOINTSTEM,’ which is a degenerative arthritis stem cell therapy product, were released in the world-renowned academic journal “Stem Cell.” Recently, commercial clinical trial phase 2B was successfully completed. It could be put forward for new drug approval from the KFDA. In the U.S, the institute has already obtained phase II commercial trial regarding ‘JOINTSTEM’ from the FDA, and a clinical trial regarding the product has been ongoing.
By continuously accumulating research results, Biostar Stem Cell Research Institute has developed special stem cells technology, allowing them to be used to treat Alzheimer’s disease by administering stem cells intravenously ten times (200 million cells/1 time). The initiation of commercial clinical trials in the U.S. regarding Alzheimer’s disease is expected to become a new milestone for Biostar Stem Cell Research Institute’s development of stem cell drug products.
Through clinical trials to be conducted in the U.S., it is expected that the technology for administering stem cells intravenously multiple times will become the world standard technology.
The representative remedy for Alzheimer's disease has been medicine with Donepezil HCI, which slows down symptoms. ASTROSTEM not only slows down symptoms of Alzheimer’s disease but may also reverse functions for good quality of life, allowing it to be greatly differentiated from existing remedies.
The clinical trials will be conducted at Syrentis Clinical Research and ATP Clinical Research located in California, a hospital in Hawaii will also conduct clinical trials.
Jeong-chan Ra, the director of Biostar Stem Cell Research Institute and leader of the clinical trial on Alzheimer's disease, said, “Autologous stem cells are very different in terms of their effects and safety, according to the culturing technology. We expect that ASTROSTEM, which was manufactured with the new and innovative stem cell technology developed in 2015, will demonstrate safety and effects for Alzheimer's disease treatment.”
