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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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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

Health and Medicine Division

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

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 & 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 & 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.

International Standard Book Number-13: 978-0-309-48909-6
International Standard Book Number-10: 0-309-48909-1
Digital Object Identifier: https://doi.org/10.17226/25371

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2019. Exploring sources of variability related to the clinical translation of regenerative engineering products: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25371.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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PLANNING COMMITTEE ON EXPLORING SOURCES OF VARIABILITY RELATED TO THE CLINICAL TRANSLATION OF REGENERATIVE ENGINEERING PRODUCTS1

MARTHA LUNDBERG (Co-Chair), Program Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health

KATHERINE TSOKAS (Co-Chair), Regulatory Head of Regenerative Medicine and Advanced Therapy, Johnson & Johnson

BRIAN FISKE, Senior Vice President, Research Programs, The Michael J. Fox Foundation for Parkinson’s Research

CATO T. LAURENCIN, Director, Institute for Regenerative Engineering; Chief Executive Officer, Connecticut Institute for Clinical and Translational Science; Distinguished Professor of Orthopedic Surgery and Chemical, Material, and Biomolecular Engineering, University of Connecticut Health Center

ANNE PLANT, Chief of the Biosystems and Materials Division, National Institute of Standards and Technology

KRISHNENDU ROY, Robert A. Milton Chair in Biomedical Engineering; Technical Lead, National Cell Manufacturing Consortium; Director, Marcus Center for Cell-Therapy Characterization and Manufacturing, Georgia Institute of Technology

SOHEL TALIB, Scientific Program Officer, California Institute for Regenerative Medicine

DANIEL WEISS, Chief Scientific Officer, International Society for Cellular Therapy

Forum on Regenerative Medicine Staff

SARAH H. BEACHY, Senior Program Officer and Forum Director

SIOBHAN ADDIE, Program Officer

ARIEL MARKOWITZ-SHULMAN, Associate Program Officer (until June 2018)

MEREDITH HACKMANN, Research Associate

REBECCA RAY, Senior Program Assistant (until December 2018)

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×

Board on Health Sciences Policy Staff

MARIAM SHELTON, Program Coordinator (from September 2018)

ANDREW M. POPE, Board Director

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×

FORUM ON REGENERATIVE MEDICINE1

JAY P. SIEGEL (Co-Chair) (retired), Chief Biotechnology Officer and Head, Scientific Strategy and Policy, Johnson & Johnson

SHARON TERRY (Co-Chair), President and Chief Executive Officer, Genetic Alliance

JAMES C. BECK, Vice President, Scientific Affairs, Parkinson’s Foundation

SANGEETA BHATIA, John J. and Dorothy Wilson Professor, Institute for Medical Engineering and Science, Electrical Engineering and Computer Science, Massachusetts Institute of Technology

LUCIE BRUIJN, Chief Scientist, ALS Association

GEORGE Q. DALEY, Director, Stem Cell Transplantation Program, Boston Children’s Hospital and Dana-Farber Cancer Institute; Dean, Harvard Medical School

CYNTHIA DUNBAR, Past President, American Society of Gene & Cell Therapy (until January 2019)

BRIAN FISKE, Senior Vice President, Research Programs, The Michael J. Fox Foundation for Parkinson’s Research

LAWRENCE GOLDSTEIN, Distinguished Professor, Department of Cellular and Molecular Medicine, Department of Neurosciences; Director, University of California, San Diego, Stem Cell Program; Scientific Director, Sanford Consortium for Regenerative Medicine; Director, Sanford Stem Cell Clinical Center, University of California, San Diego, School of Medicine

ROSEMARIE HUNZIKER, Director of Tissue Engineering and Regenerative Medicine, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health (until December 2018)

SEIGO IZUMO, Global Head, Regenerative Medicine, Takeda Development Center Americas

RUSSELL KELLEY, Program Officer, Interfaces in Science and Regulatory Science, Burroughs Wellcome Fund (until June 2018)

AUDREY KUSIAK, Scientific Program Manager, Rehabilitation Research and Development Service, Office of Research and Development, Department of Veterans Affairs

ROBERT S. LANGER, David H. Koch Institute Professor, Massachusetts Institute of Technology

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×

CATO T. LAURENCIN, Director, Institute for Regenerative Engineering; Chief Executive Officer, Connecticut Institute for Clinical and Translational Science; Distinguished Professor of Orthopedic Surgery and Chemical, Material and Biomolecular Engineering, University of Connecticut Health Center

JOHN LEPORE, Senior Vice President, Research and Development Pipeline, GlaxoSmithKline

MARTHA LUNDBERG, Program Director, Division of Cardiovascular Sciences, Advanced Technologies and Surgery Branch, National Heart, Lung, and Blood Institute, National Institutes of Health (until December 2018)

TERRY MAGNUSON, Sarah Graham Kenan Professor, Vice Chancellor for Research, University of North Carolina at Chapel Hill

MICHAEL MAY, President and Chief Executive Officer, Centre for Commercialization of Regenerative Medicine

RICHARD MCFARLAND, Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute

JACK MOSHER, Senior Manager, Scientific Affairs, International Society for Stem Cell Research

DUANQING PEI, Director General, Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences

THOMAS PETERSEN, Vice President, Regenerative Medicine, United Therapeutics Corporation

ANNE PLANT, Chief of the Biosystems and Materials Division, National Institute of Standards and Technology

DEREK ROBERTSON, Co-Founder and President, Maryland Sickle Cell Disease Association

KELLY ROSE, Program Officer, Burroughs Wellcome Fund (from January 2019)

KRISHNENDU ROY, Robert A. Milton Chair in Biomedical Engineering; Technical Lead, National Cell Manufacturing Consortium; Director, Marcus Center for Cell-Therapy Characterization and Manufacturing, Georgia Institute of Technology

KRISHANU SAHA, Assistant Professor, Department of Biomedical Engineering, Wisconsin Institute for Discovery, University of Wisconsin–Madison

RACHEL SALZMAN, Society Officer, American Society of Gene & Cell Therapy (from January 2019)

MARTHA SOMERMAN, Director, National Institute of Dental and Craniofacial Research, National Institutes of Health

LISA STROVINK, Chief Strategy Officer, The New York Stem Cell Foundation

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×

SOHEL TALIB, Scientific Program Officer, California Institute for Regenerative Medicine

KATHERINE TSOKAS, Regulatory Head of Regenerative Medicine and Advanced Therapy, Johnson & Johnson

PHIL VANEK, General Manager, Cell Therapy Growth Strategy, GE Healthcare

DANIEL WEISS, Chief Scientific Officer, International Society for Cellular Therapy

MICHAEL WERNER, Co-Founder and Senior Policy Counsel, Alliance for Regenerative Medicine

CELIA WITTEN, Deputy Director, Center for Biologics Evaluation and Research, Food and Drug Administration

CLAUDIA ZYLBERBERG, Founder and Chief Executive Officer, Akron Biotech

Forum on Regenerative Medicine Staff

SARAH H. BEACHY, Senior Program Officer and Forum Director

SIOBHAN ADDIE, Program Officer

MEREDITH HACKMANN, Research Associate

MICHAEL BERRIOS, Senior Program Assistant (from December 2018)

REBECCA RAY, Senior Program Assistant (until December 2018)

Board on Health Sciences Policy Staff

MARIAM SHELTON, Program Coordinator (from September 2018)

ANDREW M. POPE, Board Director

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making its published proceedings as sound as possible and to ensure that it meets institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We thank the following individuals for their review of this proceedings:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings, nor did they see the final draft before its release. The review of this proceedings was overseen by LINDA DEGUTIS, Henry M. Jackson Foundation. She was responsible for making certain that an independent examination of this proceedings was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Acknowledgments

The support of the sponsors of the Forum on Regenerative Medicine was crucial to the planning and conduct of the workshop Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products and for the development of this Proceedings of a Workshop. Federal sponsors were the Department of Veterans Affairs; Food and Drug Administration; National Institute of Standards and Technology; and National Institutes of Health: 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. Nonfederal sponsorship was provided by Advanced Regenerative Manufacturing Institute; Akron Biotech; Alliance for Regenerative Medicine; ALS Association; American Society of Gene & Cell Therapy; Burroughs Wellcome Fund; California Institute for Regenerative Medicine; Centre for Commercialization of Regenerative Medicine; GE Healthcare; GlaxoSmithKline; International Society for Cellular Therapy; International Society for Stem Cell Research; Johnson & Johnson; Juno Therapeutics; The Michael J. Fox Foundation for Parkinson’s Research; The New York Stem Cell Foundation; Parkinson’s Foundation; Takeda Development Center Americas; and United Therapeutics Corporation.

The Forum on Regenerative Medicine wishes to express gratitude to the expert speakers who explored the factors that contribute to variability in the development and clinical application of regenerative engineering

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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products. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda. The project director would like to thank the project staff who worked diligently to develop both the workshop and the resulting Proceedings of a Workshop.

Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Acronyms and Abbreviations

ALL acute lymphocytic leukemia
ALS amyotrophic lateral sclerosis
CAR chimeric antigen receptor
CFU colony forming unit
cGMP current good manufacturing practice
CIRM California Institute for Regenerative Medicine
CLL chronic lymphocytic leukemia
CMC chemistry, manufacturing, and controls
FDA Food and Drug Administration
GDNF glial cell line–derived neurotrophic factor
GMP good manufacturing practice
IDCT Injectable Disc Cell Therapy
IL interleukin
IND investigational new drug
iPSC induced pluripotent stem cell
LFOV large field of view
MI myocardial infarction
MSC mesenchymal stromal cell
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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NIH National Institutes of Health
PBMC peripheral blood mononuclear cell
RMAT Regenerative Medicine Advanced Therapy (designation)
SOP standard operating procedure
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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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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