Nature Cell’s Astrostem, the first stem cell-based treatment for Alzheimer’s disease, was approved by the US FDA for phases 1 and 2 of commercial clinical trials
- World’s first official clinical trials where patients’ own fat stem cells are cultivated and repeatedly administered intravenously
- Patients will be recruited later this year from 2 hospitals in the US
A stem cell treatment for Alzheimer’s disease was developed by Korean bio-company Nature Cell (President Jeong-chan Ra) and approved by the US FDA for commercial clinical trials in the US.
The high-tech bio-company announced that it had applied to the US FDA for phases 1 and 2 of commercial clinical trials for its Alzheimer treatment (Astrostem) on October 21 and received approval on the 23rd.
Astrostem is an adult stem cell-based therapy that extracts subcutaneous fat (about 10g) from a patient’s belly, then separates and cultivates pure stem cells and injects the final product into the patient’s veins.
The Rbio Biostar Stem Cell Research Institute will produce the clinical test drugs. The institute has been leading R&D efforts to combat dementia for over a decade.
Dr. Ra’s team at the institute, in co-research with renowned neurologist Dr. Yoo-hun Seo’s team, confirmed the safety, efficacy, and scheme of the stem cell treatment. The joint research team cultivated fat stem cells using its patented technology and then administered it to animals afflicted with Alzheimer’s disease; they then presented the results to international science journal PLoS One for global endorsement.
The current US FDA approval provides another leap forward as it represents the first commercial clinical trials for repeated intravenous administration of stem cells originally extracted from a patient’s own fat. Biostar’s technology was already approved by Japan’s Ministry of Health, Labor and Welfare as the only non-Japanese company, and it has been applied to over 3,000 patients with autoimmune diseases over the past year.
The approved clinical trials are for the cultivation of living stem cells in Korea and their administration into patients’ veins in the US. This, once again, confirms the remarkable technology of the Biostar Stem Cell Research Institute in the US, following the success of Jointstem, which is under phase 2 of clinical trials in the US. Astrostem was made possible by a series of technologies: 1) cultivating stem cells young, 2) cultivating stem cells in very small sizes, 3) keeping over 90% of stem cells alive for 7 days within the final products, and 4) cultivating stem cells that deter cancer cell growth.
Dr. Ra, who is leading the Defeating Alzheimer’s Disease campaign, stated, “I believe that it is a good opportunity for Korea to showcase its excellent stem cell technology on the international stage, as Atrostem, following our degenerative arthritis cure Jointstem, has been approved for clinical trials by the US FDA. For the future growth engine of our country, I ask that the government and the public provide every support necessary for adult stem cell research.” Dr. Ra also wrote the book “Dementia? You still have hope” in order to send a positive message to patients and families struggling with the effects of dementia.