Nature Cell Co., Ltd. started Phase I and II Commercial Clinical Trials of ‘ASTROSTEM,’ Stem Cell Drug for the Treatment of Alzheimer’s Disease in the U.S.
- Two Hospitals in the U.S. have started recruiting patients
- SEOUL, South Korea – Biotechnology company Nature Cell Co., Ltd. (KOSDAQ: 007390) (Nature Cell) announced the recruitment of 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 for Alzheimer’s disease were approved by the U.S. Food and Drug Administration (FDA) on November 24th, 2016. In February 2017, Institutional Review Board (IRB) approved the clinical trial protocol and on March 8th, 2017, the final IRB approval was obtained for Syrentis Clinical Research and ATP Clinical to conduct the clinical trials at the two hospitals in the U.S. The authorization process has been completed and the recruitment of patients has commenced.
Biostar Stem Cell Research Institute (Director: Jeong-chan Ra) (Biostar), in co-operation with Nature Cell and R Bio, has developed a technology for culturing autologous fat tissue-derived stem cells. Biostar has invested more than KRW 300 billion in its research and development efforts over the last 10 years, allowing it to develop a stem cell drug for treatments of intractable diseases through the regeneration of blood vessels, cartilage and neurons.
Biostar has already succeeded in its clinical trials for Buerger’s Disease and Parry-Romberg Disease. The results of the clinical trials for ‘JOINTSTEM’, the stem cell treatment for degenerative arthritis, were published in the respected academic journal “Stem Cells”, and recognized worldwide. Recently, the commercial clinical trial phase IIB was successfully completed, and is pending the new drug approval from the Korea Food and Drug Administration (KFDA). In the U.S., following the US FDA approval Biostar has started phase II commercial trial for ‘JOINTSTEM’.
By continuously accumulating research results, Biostar has developed special stem cell technology, allowing them to be used for treatment of Alzheimer’s disease by repeatedly administering stem cells intravenously to the patient, ten times, 200 million cells at a time. The start of US commercial clinical trials for Alzheimer’s Disease is a new milestone in the stem cell medicine development, delivered by Biostar.
Following the clinical trials in the U.S., the technology for repeated administration of stem cells intravenously will become the standard technology in the world.
Alzheimer’s disease has been treated with Donepezil HCI, which slows down its symptoms. Now, ‘ASTROSTEM’ not only slows down the symptoms of Alzheimer’s disease but may also contribute to quality of life, differentiating it from the existing remedies.
Dr. Jeong-chan Ra, the director of Biostar Stem Cell Research Institute and the leading expert in the clinical trial on Alzheimer’s disease, said, “Autologous stem cells are very different in terms of their effects and safety, due to the culturing technology used. We expect that ‘ASTROSTEM’, manufactured with the innovative stem cell technology developed in 2015, will demonstrate superior safety and effectiveness in the treatment of Alzheimer’s disease.”
Biostar Stem Cell Research Institute
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