Biotechnology enterprise Nature Cell네이처셀 successfully administered “AstroStem,”아스트로스템 an Alzheimer's stem cell treatment drug for dementia approved by the U.S. Food and Drug Administration (FDA), to its first patients, the company said Thursday.
Nature Cell received approval from the FDA in November for commercial clinical trials for AstroStem, and in March it was approved by the Institutional Review Board (IRB) and recruited patients from three clinical centers in the U.S. The first dose was administered to one of three clinical centers, the ATP clinic. The patient received 10 doses of AstroStem every two weeks and monitored for safety and efficacy for three months.
AstroStem is an autologous fat stem cell therapy drug developed by Korea Biostar Stem Cell Research Institute한국의 바이오스타 줄기세포연구원. The treatment is straightforward and safe since it is administered intravenously to the patient. Unlike the mechanism of dementia treatment so far, it acts through multifunctional functions such as anti-inflammation, cerebral vascular regeneration, neuronal cell protection, neuronal cell regeneration, and reduction of amyloid protein deposition.
Alzheimer's disease has already been shown to prevent and treat the effects of animal models of dementia and is published in the prominent international journal “Plos-One.”
Globally live cell therapies have a shelf life of up to three days, but AstroStem is a new type of technology that maintains more than 90 percent survival over seven days. At present, this technology is patented and registered all over the world, including Korea.
The technique of culturing the stem cells in small sizes to enable the intravascular administration was applied.
|A patient is administered with “AstroStem,” an Alzheimer’s stem cell treatment developed by Nature Cell and approved by the U.S. Food and Drug Administration.|
NatureCell plans to release all of the 60 patients approved by the FDA in the first half of 2018 and release the results by the end of 2018. Korea will evaluate the initial safety of three patients in the United States by the end of November and apply for a preliminary review of the clinical trial plan for conditional approval.
"Alzheimer's dementia is an indication that adult stem cell technology developed over the last 12 years is concentrated and applied,” said Ra Jeong-chan라정찬, CEO of Biostar Stem Cell. “It is a technique to cultivate autologous adipose stem cells young and safe, to grow small and to suppress cancer cells and developed to make cells more than 90 percent viable by day nine.”
He went on to say, “Thanks to the efforts of the researchers who have participated in the technology development together, the possibility of conquering dementia I hope to be confirmed.”
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