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人间充质干细胞(mesenchymal s temcells,MSCs)具有多向分化特性、免疫调节作用及体外分离培养扩增操作简便,因此国内外多家单位均开展了MSC临床试验,以预防和治疗异基因骨髓移植后移植物抗宿主病,修复骨和软骨损伤,治疗心肌梗塞和肝脏损伤等多种疾病。然而,越来越多的资料提示,在制订临床应用方案及具体实施过程中,必须考虑到细胞培养用动物血清蛋白的内在化、植入细胞体内存活以及分化专一性等诸多因素。本文综述了临床试验设计中宜注意的问题。
Mesenchymal stem cells (MSCs) have multidirectional differentiation characteristics, immunomodulatory effect and isolation and culture in vitro. Therefore, MSCs have been carried out in a number of clinical units at home and abroad to prevent and treat allogeneic bone marrow transplantation Graft-versus-host disease, repair of bone and cartilage damage, treatment of various diseases such as myocardial infarction and liver injury. However, more and more data suggest that in the formulation of clinical applications and the specific implementation process, we must take into account the internalization of animal serum protein for cell culture, the survival of the implanted cells in vivo and differentiation-specific and many other factors. This article reviews the issues that should be noted in the design of clinical trials.