Defining mesenchymal stromal cell (MSC)-derived small extracellular vesicles for therapeutic applications

Kenneth W. Witwer, Bas W.M. Van Balkom, Stefania Bruno, Andre Choo, Massimo Dominici, Mario Gimona, Andrew F. Hill, Dominique De Kleijn, Mickey Koh, Ruenn Chai Lai, S. Alex Mitsialis, Luis A. Ortiz, Eva Rohde, Takashi Asada, Wei Seong Toh, Daniel J. Weiss, Lei Zheng, Bernd Giebel, Sai Kiang Lim*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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.

Original languageEnglish
Article number1609206
Pages (from-to)1-12
JournalJournal of Extracellular Vesicles
Volume8
Issue number1
DOIs
Publication statusPublished - Dec 2019

Keywords

  • Definition
  • MSC
  • sEV
  • Therapeutics

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