2012年，美国FDA拒绝了Osiris的骨髓来源药物Prochymal的上市申请。其宣称的干细胞修复机制与其临床数据脱节，且缺乏可验证的效力测定方法支持。这一结论在Osiris的2012年SEC文件与美国FDA 2017年细胞治疗指南中均有迹可循。这一失败揭示了关键问题：缺乏有效的效力测定、未见明确的作用机制以及未证实MSC在体内发挥"干细胞"的分化能力。

为解决 MSCs 体内治疗机制不明的问题，研究人员开展 ApoMSCs 及其分泌的 MSC-ApoEVs 的研究。结果发现二者有治疗及药物 ... 并在《Stem Cell Research & Therapy》期刊上发表了名为 “Apoptotic mesenchymal stem cells and their secreted apoptotic extracellular vesicles ...

December 2024, immediately following the approval of the world's first mesenchymal stromal cells clinical trial, the U.S. FDA ...

The cells are first isolated by density gradient separation and further purified by a selective adherence technique to eliminate non-MSC contaminants to 99.5% purity. From here, Osiris expands the ...

Postgraduate Certificate in Stem Cells and Regeneration Postgraduate Diploma in Stem Cells and Regeneration MSc in Stem Cells and Regeneration. You will typically need an upper second-class honours ...

On the application portal, select MSc Reproduction and Development (Research) as your programme. After selecting this, choose MSc Development Biology and Stem Cells (Research) at plan level. This will ...

Because the manufacture of MSC cells has become “so efficient”, NurOwn can be used to “get years of therapy in one blood draw”. What’s more, the cells can be reintroduced into patients ...

In partnership with the National Institute of Allergy and Infectious Diseases, we committed nearly $4 million over five years to co-fund a major study of mesenchymal (adult) stromal cells as a new ...