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Failure to launch commercially-approved mesenchymal stromal cell therapies: what's the path forward? Proceedings of the International Society for Cell & Gene Therapy (ISCT) Annual Meeting Roundtable held in May 2023, Palais des Congrès de Paris, Organized by the ISCT MSC Scientific Committee.
Robb, Kevin P; Galipeau, Jacques; Shi, Yufang; Schuster, Michael; Martin, Ivan; Viswanathan, Sowmya.
Afiliação
  • Robb KP; 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, O
  • Galipeau J; Department of Medicine, School of Medicine and Public Health, University of Wisconsin in Madison, Madison, Wisconsin, USA; University of Wisconsin Carbone Comprehensive Cancer, University of Wisconsin in Madison, Madison, Wisconsin, USA.
  • Shi Y; CAS Key Laboratory of Tissue Microenvironment and Tumor, Shanghai Institute of Nutrition and Health, University of Chinese Academy of Sciences, Chinese Academy of Sciences, Shanghai, China; The Third Affiliated Hospital of Soochow University, The First Affiliated Hospital of Soochow University, Stat
  • Schuster M; Mesoblast Ltd., New York, New York, USA.
  • Martin I; Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland. Electronic address: ivan.martin@usb.ch.
  • Viswanathan S; 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, O
Cytotherapy ; 2023 Oct 07.
Article em En | MEDLINE | ID: mdl-37804284
Mesenchymal stromal cells (MSCs) are promising cell therapy candidates, but their debated efficacy in clinical trials still limits successful adoption. Here, we discuss proceedings from a roundtable session titled "Failure to Launch Mesenchymal Stromal Cells 10 Years Later: What's on the Horizon?" held at the International Society for Cell & Gene Therapy 2023 Annual Meeting. Panelists discussed recent progress toward developing patient-stratification approaches for MSC treatments, highlighting the role of baseline levels of inflammation in mediating MSC treatment efficacy. In addition, MSC critical quality attributes (CQAs) are beginning to be elucidated and applied to investigational MSC products, including immunomodulatory functional assays and other potency markers that will help to ensure product consistency and quality. Lastly, next-generation MSC products, such as culture-priming strategies, were discussed as a promising strategy to augment MSC basal fitness and therapeutic potency. Key variables that will need to be considered alongside investigations of patient stratification approaches, CQAs and next-generation MSC products include the specific disease target being evaluated, route of administration of the cells and cell manufacturing parameters; these factors will have to be matched with postulated mechanisms of action towards treatment efficacy. Taken together, patient stratification metrics paired with the selection of therapeutically potent MSCs (using rigorous CQAs and/or engineered MSC products) represent a path forward to improve clinical successes and regulatory endorsements.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2023 Tipo de documento: Article