Nature Cell Co.,Ltd. Receives U.S. FDA Approval for Phase I and II Alzheimer's Clinical Trial
November 28, 2016 at 09:00 am EST
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Nature Cell Co. Ltd. announced AstroStem's approval for Phase I and Phase II clinical trials for treatment of Alzheimer's disease by the U.S. Food and Drug Administration (FDA) on November 23, 2016. AstroStem is a therapeutic agent for adult stem cells that collects about 10g of fat from the patient's own abdominal subcutaneous tissue and separates only pure stem cells into a finished product, which is repeatedly administered intravenously to the patient. Production of the approved clinical trial materials will be done by the RBio Biostar Stem Cell Research Institute(Biostar), which has been developing technology for dementia reduction for more than 10 years. The approval of the US FDA is significant milestoneand is the first time in the world that a commercial clinical trial in which autologous adipose-derived stem cells are cultured and repeatedly administered intravenously has been approved. Biostar's technology for repeated intravenous administration of stem cells has already been applied more than 3,000 times in the past year to patients with autoimmune diseases who have been approved by Japan's Ministry of Health and Welfare.
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.