Measuring and Managing Batch Variation in MSC Fabrication

When:  Nov 17, 2021 from 09:00 to 10:00 (PT)
Wednesday, November 17 - 9:00 PST / 12:00 EST
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Measuring and Managing Batch Variation in MSC Fabrication

Part 2 of 5 of the ISCT Orthopedic & Musculoskeletal Therapies Committee Webinar Series

This is an ISCT Member Exclusive Webinar
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Webinar Description:

Populations of culture expanded mesenchymal stromal cells (“MSCs”) can be derived from tissue-specific connective tissue stem/progenitor cells (CTPs) from a variety of tissues.  MSC products have been developed and tested in a variety of clinical settings for musculoskeletal care.  This field is a source of substantial potential for clinical care, either for tissue regeneration or immunomodulation.  However, documenting safety, efficacy, repeatability and reproducibility has been limited by a number of factors.  Progress in the field has also been constrained by several factors, including inconsistency and diversity in; a) cell source selection and cell source documentation; b) characterization of product composition and performance attributes; and c) use of rigorous nomenclature to describe differences among cellular products.  Repeatability and reproducibility in manufacturing is also a major limitation for product definition, efficacy assessment and regulatory approval.


This webinar will provide participants with a status report on progress in the field of cellular therapy using culture expanded MSC populations, and also highlight important gaps and controversy in the field; this includes; 1) management and reporting on tissue-specific variation in starting materials; stochastic in vitro competition and product evolution during expansion; 2) critical “in-process” manufacturing parameters and controls (CPPs); 3) and defining application-specific “critical quality attributes” (CQAs).  The webinar is targeted for the needs of clinicians, scientists, product developers as well as the regulatory community in the field of musculoskeletal medicine, and has the goal of education as well as catalyzing discussion and opportunities for collaboration and consensus that may accelerate safe and effective clinical translation.

Chaired By: 

George Muschler, MD
Cleveland Clinic
United States

Dr. Muschler is a Professor of Orthopaedic Surgery and Biomedical Engineering at the Cleveland Clinic, with a clinical practice that integrates joint replacement, joint preservation, and bone and cartilage repair. 

Dr. Muschler’s Regenerative Medicine Laboratory has earned continuous federal funding for over 25 years, focusing on stem and progenitor cell biology, tissue engineering and regenerative medicine. He has served as Vice Chair of Bioengineering (2004-2013); Director of the Orthopaedic Research Center (2005-2013), Vice Chair of the Orthopaedic and Rheumatologic Institute (2007-2013) and has served as Director of the Cleveland Clinic Joint Preservation Center since 2017.

Dr. Muschler led the development of several multi-institutional collaborative translational networks. He founded and led the Ohio-based Clinical Tissue Engineering Center (2005-2012), and served as the founding Co-Director of the Armed Forces Institute of Regenerative Medicine (AFIRM) (2008-2011), dedicated to the accelerated development of therapies to serve wounded warriors.

Quantitative imaging and automation technology developed by Dr. Muschler’s team was spun off by the Cleveland Clinic in 2019 to form Cell X Technologies, Inc. Cell X focuses on transformation of cell sourcing and automated fabrication systems to accelerate the development of safe, effective, and affordable cellular therapies and cell-based products.

Dr. Muschler is currently Co-Chair of the Orthopedic and Musculoskeletal Therapies Committee of the International Society for Cell & Gene Therapy (ISCT), and served as Co-Chair of the 2021 ISCT Annual meeting.

Pamela Robey, PhD
National Institute of Dental and Craniofacial Research
United States

Dr. Robey received her BA from Susquehanna University in Selinsgrove, PA, and her MS and PhD from the Catholic University in Washington, DC. She did her post-doctoral work at the National Institute of Arthritis, Metabolism and Digestive Diseases (now the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)) on the role of defective phosphorylation of enzymes leading to lysosomal storage disease, and a staff fellowship in the National Eye Institute, where she studied retinal and ocular connective tissue diseases. Dr. Robey joined NIDCR in 1983 and established reproducible methods for culturing human bone-forming cells, in order to study the development of mineralized matrix formation. In 1992, Dr. Robey was appointed chief of Skeletal Biology Section. Dr. Robey has served as a Co-Coordinator of the NIH Bone Marrow Stromal Cell Transplantation Center (2008-2013), and is currently the acting Scientific Director of the NIH Stem Cell Characterization Facility. 



Sowmya Viswanathan, PhD
University Health Network

Dr. Viswanathan is a Scientist at the Division of Orthopedics Surgery, Schroeder Arthritis Institute, University Health Network, Krembil Research Institute, University Health Network, and an Associate Professor at the Institute of Biomedical Engineering and at the Division of Hematology, Department of Medicine of the University of Toronto.  Her research is focused on developing anti-inflammatory cell- based therapies including next generation mesenchymal stromal cell (MSC) therapies, engineered MSCs, 3D MSCs and immunotherapies.  Dr. Viswanathan’s lab is also focused on bioprocess optimization and translation of these cell-based therapies into clinical investigations. Dr. Viswanathan is a co-Principal Investigator of a recently completed trial using autologous MSCs to treat knee osteoarthritis patients, a North American first.

Dr. Viswanathan serves on several committees at the International Society for Cell and Gene Therapy (ISCT) including the Mesenchymal Stromal Cell (MSC) committee and the North American Legal and Regulatory Affairs Committee.  She is Associate Editor of Cytotherapy, the official journal for ISCT, and serves as an elected member of ISCT’s Board of Directors. Dr. Viswanathan is recipient of the 2021 American Orthopedic Society for Sports Medicine’s Biological Association Summit’s Best Research Award.

David Stroncek, MD
National Institutes for Health
United States

David Stroncek, MD is the Director of the Center for Cellular Engineering (CCE) at the NIH Clinical Center. The CCE is a comprehensive facility that develops and manufactures a wide range of cell and gene therapies for phase 1 and 2 clinical trials. The CCE manufactures Chimeric Antigen Receptor (CAR) T-cells, T-cells engineered to express cancer antigen-specific T-cell receptors, dendritic cells, natural killer cells, genetically modified hematopoietic stems cells and bone marrow stromal cells. The CCE has recently begun to produce autologous retinal pigmented epithelial cells from induced pluripotent stem cells which are being used to treat patients with age related macular degeneration.  The CCE also processes hematopoietic stem cells for transplantation. Dr. Stroncek’s research is focused on investigating new measures of cell and gene therapy quality and potency and developing new manufacturing methods to improve the consistency and quality of cell and gene therapies cells. Prior to coming to the NIH he was the Medical Director of the Blood Bank at the University of Minnesota and the Medical Director of the National Marrow Donor Program.