近日,天士力自主研发的同种异体脂肪间充质基质细胞注射液(NR-20201)获国家药品监督管理局药品审评中心(CDE)批准开展临床,治疗急性缺血性脑卒中。这是CDE批准的国内首款间充质基质细胞药的临床试验申请 ...
近期,国际学术期刊ACS Nano在线发表了石鹏教授团队以“Adhesion-assisted antioxidant-engineered mesenchymal stromal cells for enhanced cardiac repair ...
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。
December 2024, immediately following the approval of the world's first mesenchymal stromal cells clinical trial, the U.S. FDA ...
The intrinsic factor of cell senescence, PCBP2, was identified by unlabeled quantitative proteomics, and its biological role in in vitro replication senescence of human bone marrow mesenchymal stromal ...
Researcher suggests compounds secreted by high-risk MSCs that are detectable in the bloodstream could act as biomarkers for ...
Mesoblast Limited ( ($AU:MSB) ) has provided an announcement. Mesoblast Limited announced that its CEO, Silviu Itescu, will ...
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