SEOUL, Korea, Nov. 28, 2016 /PRNewswire/ -- Nature Cell Co., Ltd. (Nature Cell) (CEO, Dr. Jeongchan Ra), a leading biotechnology company, announces 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.
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.
Dr. Jeongchan Ra of Biostar has collaborated with professor Yoohun Suh, a global brain research leader, to isolate the stem cell, which was cultivated with patented technology as an animal model for Alzheimer's disease. The results were published in PLoS One, a respected scientific journal, and recognized worldwide.
The approval of the US FDA is significant milestone and 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.
The clinical approval of Nature Cell's Alzheimer's disease treatment reconfirmed that the stem cells were cultured in Korea and received intravenous administration to U.S. patients during JontStem's Phase II clinical trial in the U.S. It is a great result that affirms the technological developments of the RBio Biostar Stem Cell Research Institute:
- Technique to cultivate young stem cells,
- Techniques for culturing stem cells in small sizes,
- More than 90% of stem cells in the finished product survive for over 7 days,
- Successful development of stem cell culture technology to inhibit cancer cells.
Dr. Jeongchan Ra, who is in charge of the Alzheimer's disease Conversion Project, said, "The JointStem treatment of degenerative arthritis, AstroStem, a treatment for Alzheimer's disease, passing the U.S. FDA's examination and gaining approval to conduct clinical trials is a great opportunity. Adult stem cells are definitely Korea's future growth engine, so I ask for encouragement and support from the government and people."
Dr. Jeongchan Ra talks more about the hope of overcoming dementia in his book "Dementia, It Has A Hope Now".
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SOURCE Nature Cell Co.,Ltd.