https://orcid.org/0000-0001-5581-2354
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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.
Acknowledgments
SKL and BG initiated the project through SOCRATES. Representative members from ISCT, ISEV, ISBT and SOCRATES discussed, drafted and edited the paper. Funding was provided by The Silent Foundation, Singapore. SKL was funded by ICP I1801E0019 by ASTAR.
Disclosure
The authors report that they have no conflicts of interest in the authorship and publication of this article. SKL holds founder shares in Paracrine Therapeutics Pte Ltd.
Notes
1. (https://clinicaltrials.gov/ct2/results?cond=&term=mesenchymal+cells&cntry=&state=&city=&dist=&Search=Search Search conducted 2018–12-05, results = 964).