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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Understanding the Role of the
Immune System in Improving
Tissue Regeneration

PROCEEDINGS OF A WORKSHOP

Anna Nicholson, Samantha N. Schumm, and Sarah H. Beachy,
Rapporteurs

Forum on Regenerative Medicine

Board on Health Sciences Policy

Health and Medicine Division

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
×

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This activity was supported by contracts between the National Academy of Sciences and Advanced Regenerative Manufacturing Institute; Akron Biotech; Alliance for Regenerative Medicine; American Society of Gene & Cell Therapy; Burroughs Wellcome Fund (Grant No. 1021433); California Institute for Regenerative Medicine; Centre for Commercialization of Regenerative Medicine; Department of Veterans Affairs (Contract No. 36C24E21C0011; IFCAP-PO # 127-D12013); Food and Drug Administration: Center for Biologics Evaluation and Research (Grant No. 5R13FD006614-03); International Society for Cellular Therapy; International Society for Stem Cell Research; Johnson & Johnson; National Institute of Standards and Technology; National Institutes of Health: National Center for Advancing Translational Sciences; National Eye Institute; National Heart, Lung, and Blood Institute; National Institute on Aging; 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 (Contract No. HHSN263201800029I; Order No. 75N98019F00847; Mod. P00002); The New York Stem Cell Foundation; and United Therapeutics Corporation (No. 4500035476). Any opinions, findings, 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: 978-0-309-68817-8
International Standard Book Number-10: 0-309-68817-5
Digital Object Identifier: https://doi.org/10.17226/26551

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the role of the immune system in improving tissue regeneration: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/26551.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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PLANNING COMMITTEE ON UNDERSTANDING THE ROLE OF THE IMMUNE SYSTEM IN IMPROVING TISSUE REGENERATION1

NADYA LUMELSKY (Co-Chair), Chief, Integrative Biology and Infectious Diseases Branch; Director, Tissue Engineering and Regenerative Medicine Program, National Institute of Dental and Craniofacial Research, National Institutes of Health

KIMBERLEE POTTER (Co-Chair), Scientific Program Manager, Biomedical Laboratory R&D Service, Office of Research & Development, Department of Veterans Affairs

STEVEN BECKER, Associate Director, Office of Regenerative Medicine, National Eye Institute, National Institutes of Health (at the time the committee was formed)

JENNIFER ELISSEEFF, Jules Stein Professor, Morton Goldberg Professor; Director, Translational Tissue Engineering Center, Johns Hopkins University

SADIK KASSIM, Chief Technology Officer, Vor Biopharma

CANDACE KERR, Program Officer, Division of Aging Biology, National Institute on Aging, National Institutes of Health

CATO LAURENCIN, University Professor, Albert and Wilda Van Dusen Distinguished Professor; Director, The Raymond and Beverly Sackler Center for Biomedical, Biological, Physical, and Engineering Sciences; Chief Executive Officer, Connecticut Convergence Institute for Translation in Regenerative Engineering, University of Connecticut

RICHARD MCFARLAND, Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute

RACHEL SALZMAN, Chair, Government Relations Committee, American Society of Gene and Cell Therapy

SOHEL TALIB, Senior Science Officer and Director of Therapeutics, California Institute for Regenerative Medicine

DANIEL WEISS, Chief Scientific Officer, International Society for Cell & Gene Therapy; Professor, University of Vermont

Forum on Regenerative Medicine Staff

SARAH H. BEACHY, Senior Program Officer and Forum Director

SIOBHAN ADDIE, Program Officer (until August 2021)

MEREDITH HACKMANN, Associate Program Officer

___________________

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. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
×

SAMANTHA SCHUMM, Associate Program Officer (from September 2021)

LYDIA TEFERRA, Research Assistant

Board on Health Sciences Policy Staff

BRIDGET BOREL, Program Coordinator

ANDREW M. POPE, Senior Board Director

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
×

FORUM ON REGENERATIVE MEDICINE1

TIM COETZEE (Co-Chair), Chief Advocacy, Services, and Science Officer, National Multiple Sclerosis Society

KATHERINE TSOKAS (Co-Chair), Vice President, Regulatory, Quality, Risk Management and Drug Safety, Janssen Inc. Canada

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

PHILIP JOHN BROOKS, Program Director, Office of Rare Disease Research, National Center for Advancing Translational Sciences, National Institutes of Health

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

RENA D’SOUZA (from June 2021), Director, National Institute of Dental and Craniofacial Research, National Institutes of Health

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

CANDACE KERR, Program Officer, Stem Cell Program, Aging Physiology Branch Division of Aging Biology, National Institute on Aging, National Institutes of Health

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

CATO T. LAURENCIN, University Professor, Albert and Wilda Van Dusen Distinguished Professor of Orthopaedic Surgery, Professor of Chemical, Materials Science, and Biomedical Engineering; Director, The Raymond and Beverly Sackler Center for Biomedical, Biological, Physical, and Engineering Sciences; Chief Executive Officer, Connecticut Convergence Institute for Translation in Regenerative Engineering, University of Connecticut

TIMOTHY LAVAUTE, Program Director, Division of Neuroscience, National Institute of Neurological Disease and Stroke, National Institutes of Health

___________________

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. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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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 T. MOSHER, Senior Manager, Scientific Affairs, International Society for Stem Cell Research

AMY PATTERSON, Chief Science Advisor and Director of Scientific Research Programs, National Heart, Lung, and Blood Institute, National Institutes of Health

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, NIST Fellow, National Institute of Standards and Technology

KIMBERLEE POTTER, Scientific Program Manager, Biomedical Laboratory R&D Service, Office of Research and Development, Department of Veterans Affairs

DAVID RAMPULLA, Director, Division of Discovery Science & Technology, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health

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

KELLY ROSE, Program Officer, Burroughs Wellcome Fund

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

KRISHANU SAHA, Associate Professor and Retina Research Foundation Kathryn and Latimer Murfee Chair, Department of Biomedical Engineering, University of Wisconsin–Madison

RACHEL SALZMAN, Chair, Government Relations Committee, American Society of Gene and Cell Therapy

IVONNE SCHULMAN, Program Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health

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

LANA SKIRBOLL, Vice President, Science Policy, Sanofi

SUSAN L. SOLOMAN, Founder and Chief Executive Officer, New York Stem Cell Foundation

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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MARTHA SOMERMAN (until June 2021), Director, National Institute of Dental and Craniofacial Research, National Institutes of Health

MICHAEL STEINMETZ, Director, Division of Extramural Science Programs, National Eye Institute, National Institutes of Health

SOHEL TALIB, Senior Science Officer and Director of Therapeutics, California Institute for Regenerative Medicine

DANIEL WEISS, Chief Scientific Officer, International Society for Cell & Gene Therapy

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

CELIA WITTEN, Deputy Director, Center for Biologics Evaluation and Research, U.S. 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 (until August 2021)

MEREDITH HACKMANN, Associate Program Officer

SAMANTHA SCHUMM, Associate Program Officer (from September 2021)

LYDIA TEFERRA, Research Assistant

Board on Health Sciences Policy Staff

BRIDGET BOREL, Program Coordinator

ANDREW M. POPE, Senior Board Director

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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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 each published proceedings as sound as possible and to ensure that it meets the 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 LESLIE Z. BENET, University of California, San Francisco. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

We also thank staff member Julie Schuck for reading and providing helpful comments on this manuscript.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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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, Understanding the Role of the Immune System in Improving Tissue Regeneration, and for the development of this Proceedings of a Workshop. Federal sponsors were the Department of Veterans Affairs; U.S. Food and Drug Administration: Center for Biologics Evaluation and Research; National Institute of Standards and Technology; National Institutes of Health: National Center for Advancing Translational Sciences; National Eye Institute; National Heart, Lung, and Blood Institute; National Institute on Aging; 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; American Society of Gene & Cell Therapy; Burroughs Wellcome Fund; California Institute for Regenerative Medicine; Centre for Commercialization of Regenerative Medicine; International Society for Cellular Therapy; International Society for Stem Cell Research; Johnson & Johnson; The New York Stem Cell Foundation; and United Therapeutics Corporation.

The Forum on Regenerative Medicine wishes to express gratitude to the expert speakers who examined how modulation of the patient immune system and regenerative medicine products can improve the clinical outcomes

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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of tissue repair and regeneration in patients. 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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Acronyms and Abbreviations

15-PGDH 15-hydroxyprostaglandin dehydrogenase
ADCC antibody-dependent cell-mediated cytotoxicity
ATAC-Seq Assay for Transposase-Accessible Chromatin with sequencing
AUC area under the curve
Breg regulatory B cell
cAMP cyclic adenosine monophosphate
CAR chimeric antigen receptor
CD cluster of differentiation
CN cellular neighborhood
CODEX CO-Detection by indEXing
Co1 cytochrome C oxidase I
COX cyclooxygenase enzymes
CSF-1 colony stimulating factor-1
DAMP damage-associated molecular pattern
DEL-1 developmental endothelial locus-1
DHEA dehydroepiandrosterone
ECM extracellular matrix
EGF epidermal growth factor
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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EP4 E-type prostanoid receptor 4
ERK1/2 extracellular signal-regulated protein kinase
ESC embryonic stem cell
FAK focal adhesion kinase
FDA U.S. Food and Drug Administration
Gal Galalpha1-3Galbeta1-4GlcNAc
GVHD graft-versus-host disease
HCT hematopoietic cell transplantation
HLA human leukocyte antigen
HSCT hematopoietic stem cell transplantation
HUVEC human umbilical vein endothelial cell
ICAM-1 intercellular adhesion molecule 1
IgM immunoglobulin M
IL interleukin
iPSC induced pluripotent stem cells
LFA-1 lymphocyte function–associated antigen 1
mAb monoclonal antibody
MFGE8 milk fat globule-EGF factor 8 protein
MGH Massachusetts General Hospital
MHC major histocompatibility complex
micro-CT micro-computed tomography
miHA minor histocompatibility antigens
MMP matrix metalloproteinase
mRNA messenger RNA
MS multiple sclerosis
MSC mesenchymal stem/stromal cell
mtDNA mitochondrial DNA
mTOR mammalian target of rapamycin
MuSC muscle stem cell
MyoD myoblast determination protein 1
NF-kB nuclear factor kappa B
NHP nonhuman primate
NK natural killer
NSAID non-steroidal anti-inflammatory drug
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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P passage
PAMP pathogen-associated molecular pattern
PAX7 paired box 7
PCL polycaprolactone
PDGF platelet-derived growth factor
PD-L1 programmed death-ligand 1
PGD2 prostaglandin D2
PGE2 prostaglandin E2
PMN polymorphonuclear neutrophil
PS phosphatidylserine
RGD arginine-glycine-aspartic acid
ROC receiver operating characteristic
ROCK2 rho-associated coiled-coil-containing protein kinase
RUNX2 runt-related transcription factor 2
SASP senescent-associated secretory phenotype
SCAP senescent cell anti-apoptotic pathway
SPM specialized pro-resolving mediator
TGF-beta transforming growth factor beta
Th T helper cell
TLI total lymphoid irradiation
TMJ temporomandibular joint
TRAF3 tumor necrosis factor receptor-associated factor 3
Treg regulatory T cell
uPAR urokinase plasminogen activator receptor
VDJ variable, diversity, joining
VEGF vascular endothelial growth factor
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26551.
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The Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine convened a two-day virtual public workshop to address knowledge gaps in the understanding of promising approaches to manipulate the immune system and/or the regenerative medicine product to improve outcomes of tissue repair and regeneration in patients. The workshop, titled "Understanding the Role of the Immune System in Improving Tissue Regeneration," explored the role of the immune system in the success or failure of regenerative medicine therapies. Participants considered potential strategies to effectively "prepare" patients' immune systems to accept regenerative therapies and increase the likelihood of successful clinical outcomes and also discussed risks associated with modulating the immune system. This Proceedings of a Workshop highlights the presentations and discussions that occurred during the workshop.

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