(iPS Cells) Clinical Trial of Cultured Platelets Planned for This Year
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On April 26, 2021, Kyoto-based biotech company "Megakaryon" announced that, following evaluation by general medical institutions, the company plans to conduct a clinical trial this year using platelets cultured from iPS cells, which will be administered to patients. The trial plan has received approval from Japan's national regulatory authority, the PMDA (Pharmaceuticals and Medical Devices Agency).
The plan involves culturing platelets from third-party iPS cells donated by Kyoto University, then actually administering them to approximately 10 adult male and female participants to confirm safety and efficacy.
According to the company, the current primary source of platelets for treatment is through blood donation. However, if platelets can be cultured from iPS cells, they could potentially be produced in large quantities. The next step will be to request a further review and assessment from the affiliated hospital of Kyoto University's Faculty of Medicine, and if this review is passed, the company hopes to begin clinical trials within the year.
Source: https://www3.nhk.or.jp/news/html/20210426/k10012997531000.html
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