Mesenchymal stromal cell variables influencing clinical potency: the impact of viability,fitness, route of administration and host predisposition |
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| Authors: | Jacques Galipeau Mauro Krampera Katarina Leblanc Jan A. Nolta Donald G. Phinney Yufang Shi Karin Tarte Sowmya Viswanathan Ivan Martin |
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| Affiliation: | 1. Department of Medicine, Carbone Cancer Center, University of Wisconsin, Madison, Wisconsin, USA;2. Department of Medicine, Section of Hematology, University of Verona, Verona, Italy;3. Department of Laboratory Medicine, Center for Allogeneic Stem Cell Transplantation, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden;4. Stem Cell Program, University of California Davis, Sacramento, California, USA;5. Department of Molecular Therapeutics, Scripps Research Institute, Jupiter, Florida, USA;6. Institute for Translational Medicine, Soochow University, Suzhou, China;7. Établissement Français du Sang Bretagne, Institute for Health and Medical Research, University of Rennes, Rennes, France;8. Department of Medicine and Institute of Biomedical Engineering, Krembil Research Institute, University Health Network, University of Toronto, Toronto, Canada;9. Department of Biomedicine, University Hospital Basel, Basel, Switzerland;1. McGovern Medical School, The University of Texas Health Science Center, Houston, Texas, USA;2. Department of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA;3. Wake Forest Baptist Medical Center, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA;4. College of Arts and Sciences, Ohio State University, Columbus, Ohio, USA;5. Cellf Bio LLC, Winston-Salem, North Carolina, USA;6. Department of Medicine, Gastroenterology Unit, Giambattista Rossi University Hospital, University Hospital Integrated Trust of Verona, University of Verona, Verona, Italy;1. Biosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, Maryland, USA;2. University Health Network, Toronto, Canada;3. University of Toronto, Toronto, Canada;4. Akron Biotech, Boca Raton, Florida, USA;5. Massachusetts Institute of Technology Center for Biomedical Innovation, Boston, Massachusetts, USA;6. Frost and Sullivan, San Francisco, California, USA;7. Georgia Institute of Technology, Atlanta, Georgia, USA;8. Cell & Gene Therapy Catapult, London, UK;9. BioFabUSA, Manchester, New Hampshire, USA;10. Centre for Commercialization of Regenerative Medicine, Toronto, Canada;11. Novartis, Cambridge, Massachusetts, USA;12. Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery, Gaithersburg, Maryland, USA;1. Center for Childhood Cancer and Blood Diseases, The Research Institute at Nationwide Children''s Hospital, Columbus, Ohio, USA;2. Aflac Cancer & Blood Disorders Center, Children''s Healthcare of Atlanta, Emory University School of Medicine, Atlanta, Georgia, USA;3. Department of Medical and Surgical Sciences of Children and Adults, University of Modena and Reggio Emilia, Modena, Italy |
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| Abstract: | The International Society for Cell & Gene Therapy mesenchymal stromal cell (MSC) committee has been an interested observer of community interests in all matters related to MSC identity, mechanism of action, potency assessment and etymology, and it has regularly contributed to this conversation through a series of MSC pre-conferences and committee publications dealing with these matters. Arising from these reflections, the authors propose that an overlooked and potentially disruptive perspective is the impact of in vivo persistence on potency that is not predicted by surrogate cellular potency assays performed in vitro and how this translates to in vivo outcomes. Systemic delivery or extravascular implantation at sites removed from the affected organ system seems to be adequate in affecting clinical outcomes in many pre-clinical murine models of acute tissue injury and inflammatory pathology, including the recent European Medicines Agency-approved use of MSCs in Crohn-related fistular disease. The authors further propose that MSC viability and metabolic fitness likely dominate as a potency quality attribute, especially in recipients poised for salutary benefits as defined by emerging predictive biomarkers of response. |
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