Nature Cell Starts Commercial Clinical Trials Phase I and II ‘ASTROSTEM,’ Stem Cell Drug for Alzheimer's Disease Treatment in U.S
March 10, 2017 at 08:00 am
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Nature Cell 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 24, 2016. In February 2017, IRB approval was obtained regarding the clinical trial protocol and on March 8, 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. 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.
NatureCell Co Ltd is a Korea-based company principally engaged in the stem cell business. The Company operates its business through three segments. The Stem Cell Business segment is engaged in the development of stem cell therapeutics, the manufacture of stem cell culture media, the development and sale of stem cell culture cosmetics, and the provision of blood cell storage services, among others. The Food Business segment is engaged in the manufacture and sale of fruit beverages including tomato juice, peach juice and others, canned beverages such as sikhye, fruit concentrates and others, as well as fermentation and health functional foods. The Hygiene Business segment is engaged in the manufacture and sale of health hygiene products such as masks, disinfectants, wipes, and others.