Defining mesenchymal stromal cell (MSC)-derived small extracellular vesicles for therapeutic applications
Defining mesenchymal stromal cell (MSC)-derived small extracellular vesicles for therapeutic applications
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DOI：
10.1080/20013078.2019.1609206
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发表时间：
2019-01-01
影响因子：
16
通讯作者：
Lim, Sai Kiang
中科院分区：
文献类型：
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作者：
Witwer, Kenneth W.;Van Balkom, Bas W. M.;Lim, Sai Kiang
来自间充质基质/干细胞（MSCs）的小细胞外囊泡（sev）正在迅速走向临床应用。然而，关于msc - sev的生物学、功能和效力的差异和争议由于以下几个因素而产生：msc的多样性及其制备；各种sEV生产和分离方法；缺乏标准化的质量保证分析；体外和体内功能分析的可重复性有限。为了解决这些问题，四个协会（SOCRATES， ISEV， ISCT和ISBT）的成员提出了msc - sev的具体协调标准，以促进数据共享和比较，这将有助于推动该领域向临床应用发展。具体来说，msc - sev应该通过可量化的指标来定义，以确定制剂中sev的细胞起源、脂质膜囊泡的存在以及囊泡的物理和生化完整性程度。在实际应用中，新的MSC-sEV制剂也可以用表征良好的MSC-sEV生物参比物进行测量。开发这些指标的最终目标是将MSC-sEV生物学和治疗效力的各个方面映射到每种制剂的可量化特征上。
Small extracellular vesicles (sEVs) from mesenchymal stromal/stem cells (MSCs) are transiting rapidly towards clinical applications. However, discrepancies and controversies about the biology, functions, and potency of MSC-sEVs have arisen due to several factors: the diversity of MSCs and their preparation; various methods of sEV production and separation; a lack of standardized quality assurance assays; and limited reproducibility of in vitro and in vivo functional assays. To address these issues, members of four societies (SOCRATES, ISEV, ISCT and ISBT) propose specific harmonization criteria for MSC-sEVs to facilitate data sharing and comparison, which should help to advance the field towards clinical applications. Specifically, MSC-sEVs should be defined by quantifiable metrics to identify the cellular origin of the sEVs in a preparation, presence of lipid-membrane vesicles, and the degree of physical and biochemical integrity of the vesicles. For practical purposes, new MSC-sEV preparations might also be measured against a well-characterized MSC-sEV biological reference. The ultimate goal of developing these metrics is to map aspects of MSC-sEV biology and therapeutic potency onto quantifiable features of each preparation.