National Academies Press: OpenBook
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Exploring the State of the
Science in the Field of
Regenerative Medicine

CHALLENGES OF AND OPPORTUNITIES FOR
CELLULAR THERAPIES

Proceedings of a Workshop

Ariel Markowitz-Shulman, Erin Hammers-Forstag, Siobhan Addie,
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. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001

This project was supported by contracts between the National Academy of Sciences and Akron Biotech (unnumbered contract); Alliance for Regenerative Medicine (unnumbered contract); ALS Association (unnumbered contract); American Association of Gene and Cell Therapy (unnumbered contract); Burroughs Wellcome Fund (Grant #1015949); California Institute for Regenerative Medicine (unnumbered contract); Centre for Commercialization of Regenerative Medicine (unnumbered contract); Christopher & Dana Reeve Foundation (unnumbered contract); Department of Veterans Affairs (Contract No. VA268-16-C-0051); Food and Drug Administration (Grant #1R13FD005355-01); Foundation Fighting Blindness (unnumbered contract); GE Healthcare (unnumbered contract); GlaxoSmithKline (Grant ID: 015948); 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; National Institute of Neurological Disorders and Stroke); The New York Stem Cell Foundation (unnumbered contract); Parkinson’s Disease Foundation (unnumbered contract); Takeda Development Centers America (Contract #65317); and United Therapeutics Corporation (unnumbered contract). 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: 978-0-309-45508-4
International Standard Book Number-10: 0-309-45508-1
Digital Object Identifier: https://doi.org/10.17226/24671

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the state of the science in the field of regenerative medicine: Challenges of and opportunities for cellular therapies: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24671.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
×

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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Reports document the evidence-based consensus of an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and committee deliberations. Reports are peer reviewed and are approved by the National Academies of Sciences, Engineering, and Medicine.

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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PLANNING COMMITTEE FOR EXPLORING THE STATE OF THE SCIENCE IN THE FIELD OF REGERNERATIVE MEDICINE: CHALLENGES OF AND OPPORTUNITIES FOR CELLULAR THERAPIES1

CYNTHIA DUNBAR (Co-Chair), President, American Society for Cell and Gene Therapy

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

JAMES BECK, Vice President, Scientific Affairs, Parkinson’s Disease Foundation

R. ALTA CHARO, Warren P. Knowles Professor of Law and Bioethics, School of Law and School of Medicine and Public Health, University of Wisconsin–Madison

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

MARK FROLICH, Executive Vice President, Portfolio Strategy, Juno Therapeutics

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

DEBORAH HOSHIZAKI, Program Director, Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health

SUSAN HOWLEY, Executive Vice President, Research, Christopher & Dana Reeve Foundation

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

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

___________________

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. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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CATO T. LAURENCIN, Director, Institute for Regenerative Engineering; Chief Executive Officer, Connecticut Institute for Clinical and Translational Science; Distinguished Professor of Orthopaedic Surgery and Chemical, Material and Biomolecular Engineering, University of Connecticut Health Center

RICHARD MCFARLAND, Associate Director for Policy, Office of Cellular, Tissue, and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration

THOMAS PETERSEN, Principal Scientist, United Therapeutics Corporation

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

HEATHER ROOKE, Scientific Director, International Society for Stem Cell Research

STEPHEN ROSE, Chief Research Officer, Foundation Fighting Blindness

KRISHNENDU ROY, Robert A. Milton Chair and Professor Technical Lead, National Cell Manufacturing Consortium, Georgia Institute of Technology

JAY SIEGEL, Chief Biotechnology Officer and Head, Scientific Strategy and Policy, Johnson & Johnson

MARTHA SOMERMAN, Director, National Institute of Dental and Craniofacial Research; Chief, Laboratory for Oral Connective Tissue Biology, National Institute of Arthritis and Musculoskeletal and Skin Disease, National Institutes of Health

MICHAEL WERNER, Executive Director, Alliance for Regenerative Medicine

JIWEN ZHANG, Senior Director, Regulatory Affairs, Cell Therapy and Regenerative Medicine, GE Healthcare

CLAUDIA ZYLBERBERG, Founder and Chief Executive Officer, Akron Biotech

Health and Medicine Division Staff

SARAH H. BEACHY, Project Director

ARIEL MARKOWITZ-SHULMAN, Associate Program Officer

MEREDITH HACKMANN, Senior Program Assistant

SIOBHAN ADDIE, Associate Program Officer

HILARY BRAGG, Program Coordinator

ANDREW M. POPE, Board Director

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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FORUM ON REGENERATIVE MEDICINE1

R. ALTA CHARO (Co-Chair), Warren P. Knowles Professor of Law and Bioethics, School of Law and School of Medicine and Public Health, University of Wisconsin–Madison

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

SALVATORE ALESCI, Head, Research and Development Global Science and Biomedical Policy, Strategic and Professional Affairs, Takeda Development Center Americas

JAMES C. BECK, Vice President, Scientific Affairs, Parkinson’s Disease 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, President, American Society for Cell and Gene Therapy

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

MARK FROLICH, Executive Vice President, Portfolio Strategy, Juno Therapeutics

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

SUSAN HOWLEY, Executive Vice President, Research, Christopher & Dana Reeve Foundation

RUSSELL KELLEY, Program Officer, Interfaces in Science and Regulatory Science, Burroughs Wellcome Fund

___________________

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. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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WALTER KOROSHETZ, Director, National Institute of Neurological Disorders and Stroke, National Institutes of Health

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

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

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

THOMAS PETERSEN, Principal Scientist, United Therapeutics Corporation

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

GRIFFIN RODGERS, Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health

HEATHER ROOKE, Scientific Director, International Society for Stem Cell Research

STEPHEN ROSE, Chief Research Officer, Foundation Fighting Blindness

KRISHNENDU ROY, Robert A. Milton Chair and Professor Technical Lead, National Cell Manufacturing Consortium, Georgia Institute of Technology

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

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

SHARON TERRY, President and Chief Executive Officer, Genetic Alliance

MICHAEL WERNER, Executive Director, Alliance for Regenerative Medicine

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
×

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

MICHAEL YAFFE, Vice President, Scientific Programs, The New York Stem Cell Foundation

JIWEN ZHANG, Senior Director, Regulatory Affairs, Cell Therapy and Regenerative Medicine, GE Healthcare

CLAUDIA ZYLBERBERG, Founder and Chief Executive Officer, Akron Biotech

Health and Medicine Division Staff

SARAH H. BEACHY, Project Director

ARIEL MARKOWITZ-SHULMAN, Associate Program Officer

MEREDITH HACKMANN, Senior Program Assistant

SIOBHAN ADDIE, Associate Program Officer

HILARY BRAGG, Program Coordinator

ANDREW M. POPE, Board Director

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Reviewers

This Proceedings of a Workshop has been 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 institution in making its published Proceedings of a Workshop as sound as possible and to ensure that the Proceedings of a Workshop meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this Proceedings of a Workshop:

DAVID BARON, Polycystic Kidney Disease Foundation

RACHEL HADDOCK, GlaxoSmithKline

LAURA NIKLASON, Yale School of Engineering and Applied Science

JOHN WAGNER, University of Minnesota Medical School

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the Proceedings of a Workshop before its release. The review of this Proceedings of a Workshop was overseen by MELVIN WORTH. He was responsible for making certain that an independent examination of this Proceedings of a Workshop was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this Proceedings of a Workshop rests entirely with the rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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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, State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies, 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; National Institute of Neurological Disorders and Stroke. Nonfederal sponsorship was provided by Akron Biotech; Alliance for Regenerative Medicine; ALS Association; American Association of Gene and Cell Therapy; Burroughs Wellcome Fund; California Institute for Regenerative Medicine; Centre for Commercialization of Regenerative Medicine; Christopher & Dana Reeve Foundation; Foundation Fighting Blindness; GE Healthcare; GlaxoSmithKline; 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 Disease Foundation; Takeda Development Centers America; and United Therapeutics Corporation.

The Forum on Regenerative Medicine wishes to express gratitude to the expert speakers who explored opportunities and challenges associated with developing regenerative medicine cellular therapies and related technologies. The forum also wishes to thank the members of the plan-

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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ning 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 xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Acronyms and Abbreviations

A2AR adenosine A2A receptor
AAV adeno-associated viruses
ADPKD autosomal dominant polycystic kidney disease
ALS amyotrophic lateral sclerosis
AMD age-related macular degeneration
CADUCEUS Cardiosphere-Derived Autologous Stem Cells to Reverse Ventricular Dysfunction (trial)
CAR chimeric antigen receptor
CDC cardiosphere-derived cell
CF cystic fibrosis
CNS central nervous system
CRISPR clustered regularly interspaced short palindromic repeat
DEB dystrophic epidermolysis bullosa
DMD Duchenne muscular dystrophy
DNA deoxyribonucleic acid
ESRD end-stage renal disease
FDA Food and Drug Administration
GFR glomerular filtration rate
GMP good manufacturing practice
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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GMT Gata-4, Mef2c, and Tbx5
GVHD graft-versus-host disease
hESC human embryonic stem cell
HIV human immunodeficiency virus
HLA human leukocyte antigen
hPS human pluripotent stem (cell)
HSCT hematopoietic stem cell transplantation
HSPC hematopoietic stem/progenitor cell
HuCNS-SC human neural stem cell
huKO humanized Kusabira–Orange
IMPD investigational medicinal product dossier
IND investigational new drug
IPF idiopathic pulmonary fibrosis
iPS induced pluripotent stem (cell)
ISSCR International Society for Stem Cell Research
LEAES LZRSE-Col7A1 engineered autologous epidermal sheets
MLV murine leukemia virus
MRI magnetic resonance imaging
PERV porcine endogenous retrovirus
PKD polycystic kidney disease
PPMD Parent Project Muscular Dystrophy
RCS Royal College of Surgeons
REGROW Reliable and Effective Growth for Regenerative Health Options to Improve Wellness
RNA ribonucleic acid
ROI return on investment
RPE retinal pigment epithelium
RPESC retinal pigment epithelial stem cell
SNP single nucleotide polymorphism
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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UK United Kingdom
VST virus-specific T cell
X-linked SCID X-linked severe combined immune deficiency
ZFN zinc finger nuclease
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24671.
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Regenerative medicine holds the potential to create living, functional cells and tissues that can be used to repair or replace those that have suffered potentially irreparable damage due to disease, age, traumatic injury, or genetic and congenital defects. The field of regenerative medicine is broad and includes research and development components of gene and cell therapies, tissue engineering, and non-biologic constructs. Although regenerative medicine has the potential to improve health and deliver economic benefits, this relatively new field faces challenges to developing policies and procedures to support the development of novel therapies are both safe and effective.

In October 2016, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop with the goal of developing a broad understanding of the opportunities and challenges associated with regenerative medicine cellular therapies and related technologies. Participants explored the state of the science of cell-based regenerative therapies within the larger context of patient care and policy. This publication summarizes the presentations and discussions from the workshop.

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