%0 Journal Article %T Defining mesenchymal stromal cell (MSC)-derived small extracellular vesicles for therapeutic applications %A Andre Choo %A Andrew F. Hill %A Bas W.M. Van Balkom %A Bernd Giebel %A Daniel J. Weiss %A Dominique De Kleijn %A Eva Rohde %A Kenneth W. Witwer %A Lei Zheng %A Luis A. Ortiz %A Mario Gimona %A Massimo Dominici %A Mickey Koh %A Ruenn Chai Lai %A S. Alex Mitsialis %A Sai Kiang Lim %A Stefania Bruno %A Takashi Asada %A Wei Seong Toh %J Journal of Extracellular Vesicles %D 2019 %R https://doi.org/10.1080/20013078.2019.1609206 %X 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 %U https://www.tandfonline.com/doi/full/10.1080/20013078.2019.1609206