Witwer, Kenneth W ORCID: 0000-0003-1664-4233, van Balkom, Bas WM, Bruno, Stefania, Choo, Andre, Dominici, Massimo, Gimona, Mario, Hill, Andrew F ORCID: 0000-0001-5581-2354, de Kleijn, Dominique, Koh, Mickey, Lai, Ruenn Chai, Mitsialis, S Alex, Ortiz, Luis A, Rohde, Eva, Asada, Takashi, Toh, Wei Seong, Weiss, Daniel J, Zheng, Lei, Giebel, Bernd and Lim, Sai Kiang (2019) Defining mesenchymal stromal cell (MSC)-derived small extracellular vesicles for therapeutic applications. Journal of Extracellular Vesicles, 8 (1). ISSN 2001-3078

Abstract

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.

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