An International Society for Cell and Gene Therapy Mesenchymal Stromal Cells (MSC) Committee perspectives on International Standards Organization/Technical Committee 276 Biobanking Standards for bone marrow-MSCs and umbilical cord tissue-derived MSCs for research purposes

Sowmya Viswanathan; Katarina Le Blanc; Rachele Ciccocioppo; Georges Dagher; Anthony J Filiano; Jacques Galipeau; Mauro Krampera; Lena Krieger; Manoj M Lalu; Jan Nolta; Viviana Marcela Rodriguez Pardo; Yufang Shi; Karin Tarte; Daniel J Weiss; Ivan Martin

doi:10.1016/j.jcyt.2023.04.005

An International Society for Cell and Gene Therapy Mesenchymal Stromal Cells (MSC) Committee perspectives on International Standards Organization/Technical Committee 276 Biobanking Standards for bone marrow-MSCs and umbilical cord tissue-derived MSCs for research purposes

Cytotherapy. 2023 Aug;25(8):803-807. doi: 10.1016/j.jcyt.2023.04.005. Epub 2023 May 6.

Authors

Affiliations

¹ Osteoarthritis Research Program, Division of Orthopedic Surgery, Schroeder Arthritis Institute, University Health Network, Toronto, Ontario, Canada; Krembil Research Institute, University Health Network, Toronto, Ontario, Canada; Institute of Biomedical Engineering, University of Toronto, Toronto, Ontario, Canada; Department of Medicine, Division of Hematology, University of Toronto, Toronto, Ontario, Canada. Electronic address: sowmya.viswanathan@uhnresearch.ca.
² Division of Clinical Immunology and Transfusion Medicine, Karolinska Institutet, Stockholm, Sweden.
³ Department of Medicine, AOUI Policlinico GB Rossi & University of Verona, Verona, Italy.
⁴ Inserm UMR-S 1124, Paris-Descartes University, Paris, France.
⁵ Department of Neurosurgery, Duke University, Durham, North Carolina, USA; Marcus Center for Cellular Cures, Duke University Medical Center, Durham, North Carolina, USA.
⁶ Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, USA.
⁷ Department of Medicine, Section of Hematology, University of Verona, Verona, Italy.
⁸ DIN - German Institute for Standardization, Berlin, Germany.
⁹ Clinical Epidemiology Program, Blueprint Translational Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada; Regenerative Medicine Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹⁰ Department of Internal Medicine, Stem Cell Program and Institute for Regenerative Cures, University of California Davis, Sacramento, California, USA.
¹¹ Grupo de Inmunobiología y Biología Celular, Facultad de Ciencias, Pontificia Universidad Javeriana. Bogotá, Colombia; Biotechnology National Committee Convenor, National Standars of Colombia - ICONTEC. Bogotá, Colombia.
¹² The First Affiliated Hospital, Soochow University Institutes for Translational Medicine, Suzhou, China; Institute of Health Sciences, Chinese Academy of Sciences, Shanghai, China.
¹³ UMR U1236-MICMAC, Immunology and Cell Therapy Lab, Rennes University Hospital, Rennes, France.
¹⁴ University of Vermont College of Medicine, Burlington, Vermont, USA.
¹⁵ Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland.

PMID: 37149800
DOI: 10.1016/j.jcyt.2023.04.005

Abstract

The rapidly growing field of mesenchymal stromal cell (MSC) basic and translational research requires standardization of terminology and functional characterization. The International Standards Organization's (ISO) Technical Committee (TC) on Biotechnology, working with extensive input from the International Society for Cells and Gene Therapy (ISCT), has recently published ISO standardization documents that are focused on biobanking of MSCs from two tissue sources, Wharton's Jelly, MSC(WJ) and Bone Marrow, MSC(M)), for research and development purposes and development. This manuscript explains the path towards the consensus on the following two documents: the Technical Standard ISO/TS 22859 for MSC(WJ) and the full ISO Standard 24651 for MSC(M) biobanking. The ISO standardization documents are aligned with ISCT's MSC committee position and recommendations on nomenclature because there was active input and incorporation of ISCT MSC committee recommendations in the development of these standards. The ISO standardization documents contain both requirements and recommendations for functional characterization of MSC(WJ) and MSC(M) using a matrix of assays. Importantly, the ISO standardization documents have a carefully defined scope and are meant for research use of culture expanded MSC(WJ) and MSC(M). The ISO standardization documents can be updated in a revision process and will be systematically reviewed after 3-5 years as scientific insights grow. They represent international consensus on MSC identity, definition, and characterization; are rigorous in detailing multivariate characterization of MSCs and represent an evolving-but-important first step in standardization of MSC biobanking and characterization for research use and development.

Keywords: MSC; Wharton's Jelly; biobanking; bone marrow; culture-expanded MSCs; functional characterization; nomenclature; standards.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biological Specimen Banks
Bone Marrow
Cell Differentiation
Cell Proliferation
Cells, Cultured
Mesenchymal Stem Cells*
Umbilical Cord
Wharton Jelly*