Exploring sources of variability related to the clinical translation of regenerative engineering products : proceedings of a workshop / Meredith Hackmann, Theresa Wizemann, and Sarah H. Beachy, rapporteurs ; Forum on Regenerative Medicine, Board on Health Sciences Policy, National Academies of Sciences, Engineering, Medicine.

Includes bibliographical references.

The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results. The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.

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This activity was supported by contracts between the National Academy of Sciences and Advanced Regenerative Manufacturing Institute (unnumbered contract); Akron Biotech (unnumbered contract); Alliance for Regenerative Medicine (unnumbered contract); ALS Association (unnumbered contract); American Society of Gene and Cell Therapy (unnumbered contract); Burroughs Wellcome Fund (unnumbered contract); California Institute for Regenerative Medicine (unnumbered contract); Centre for Commercialization of Regenerative Medicine (unnumbered contract); Department of Veterans Affairs (Contract No. VA268-16-C-0051); Food and Drug Administration (Grant #1R13FD0066--14-01); GE Healthcare (unnumbered contract); GlaxoSmithKline (unnumbered contract); International Society for Cellular Therapy (unnumbered contract); International Society for Stem Cell Research (unnumbered contract); Johnson and Johnson (unnumbered contract); Juno Therapeutics (unnumbered contract); The Michael J. Fox Foundation for Parkinson's Research (unnumbered contract); National Institute of Standards and Technology (unnumbered contract); National Institutes of Health (Contract No. HHSN263201200074I, Order No. HHSN23600075: National Heart, Lung, and Blood Institute; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Biomedical Imaging and Bioengineering; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; and National Institute of Neurological Disorders and Stroke); The New York Stem Cell Foundation (unnumbered contract); Parkinson's Foundation (unnumbered contract); Takeda Development Center Americas (unnumbered contract); and United Therapeutics Corporation (#10003921). Any opinions, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

Introduction and overview -- Sources of variability associated with regenerative therapies : lessons from case studies -- Factors contributing to patient variability -- Addressing variability in donor tissues and cells -- Addressing variability and meeting quality expectations in the manufacturing setting -- Exploring variability and its impact on product regulation and outcomes -- Potential next steps to consider for addressing variability -- References -- Appendixes