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J Extracell Vesicles. 2019 Apr 29;8(1):1609206. doi: 10.1080/20013078.2019.1609206. eCollection 2019.

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

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Department of Molecular and Comparative Pathobiology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Department of Neurology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Division Internal Medicine and Dermatology, Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Medical Sciences and Molecular Biotechnology Center, University of Torino, Torino, Italy.
Bioprocessing Technology Institute, Agency for Science, Technology and Research, Singapore, Singapore.
MAB Laboratory, TPM of Mirandola, Mirandola, Italy.
Division of Oncology, University of Modena and Reggio Emilia, Modena, Italy.
GMP Laboratory, Spinal Cord Injury and Tissue Regeneration Center Salzburg (SCI-TReCS), Research Program Nanovesicular Therapies, Department of Transfusion Medicine and Celericon Therapeutics G.m.b.H., Paracelsus Medical University (PMU), Salzburg, Austria.
Department of Biochemistry and Genetics, La Trobe Institute for Molecular Science, La Trobe University, Bundoora, Australia.
Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Haematology, St George's University Hospital NHS Trust, London, UK.
Cell Therapy Facility, Blood Services Group Health Sciences Authority, Singapore, Singapore.
Institute of Medical Biology, Agency for Science, Technology and Research, Singapore, Singapore.
Department of Pediatrics, Harvard Medical School & Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA.
Division of Environmental and Occupational Medicine, Department of Environmental and Occupational Health, Graduate School of Public Health at the University of Pittsburgh, Pittsburgh, PA, USA.
Department of Tissue Regeneration Science and Engineering, Institute for Frontier Life and Medical Sciences, Kyoto University, Kyoto, Japan.
Faculty of Dentistry, National University of Singapore, Singapore, Singapore.
Health Sciences Research Facility, University of Vermont College of Medicine, Burlington, VT, USA.
Department of Laboratory Medicine, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Institute for Transfusion Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Department of Surgery, YLL School of Medicine, National University of Singapore, Singapore, Singapore.


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.


Definition; MSC; Please check whether the inserted Keywords are correct; Therapeutics; sEV

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