laurencin - astm international...regenerative engineering, a new field described by dr. laurencin...

Bone Graft Substitutes and Bone Regenerative Engineering 2nd Edition

EditorsCato T. Laurencin, M.D., Ph. D.Tao Jiang, Ph.D., MBA

Illustration by Philip H. Ashley, C.M.I.

ASTM INTERNATIONAL Helping our world work better

ISBN: 978-0-8031-7060-5 Stock #: MONO6-2ND

www.astm.org

LaurencinJiang

Bone G

raft Substitutes and Bone

Regenerative Engineering 2nd Edition

Cato T. Laurencin M.D., Ph.D. and Tao Jiang Ph.D., MBA

Bone Graft Substitutes and Bone Regenerative Engineering—2nd Edition

ASTM Stock Number: MONO6-2ND

ASTM International

100 Barr Harbor Drive

PO Box C700

West Conshohocken, PA 19428-2959

Developed in conjunction with

American Academy of Orthopaedic Surgeons

9400 West Higgins Road

Rosemont, IL 60018-4976

Printed in the U.S.A.

BK-AST-MONO6-140378-FM.indd 1 11/10/2014 3:36:28 PM

Library of Congress Cataloging-in-Publication DataBone graft substitutes Bone graft substitutes and bone regenerative engineering / [edited by] Cato T. Laurencin, Tao Jiang. — 2nd edition. p. ; cm. Preceded by: Bone graft substitutes / edited by Cato T. Laurencin. c2003. “ASTM Stock Number: MON06-2ND”. Includes bibliographical references. ISBN 978-0-8031-7060-5 I. Laurencin, Cato T., editor. II. Jiang, Tao, 1978- editor. III. ASTM International, publisher. IV. Title. [DNLM: 1. Bone Regeneration. 2. Bone Substitutes. 3. Bone Transplantation—methods. 4. Bone Morphogenetic Proteins. 5. Growth Substances. WE 200] RD755.6 617.4’710592—dc23 2014020853

Copyright © 2014 ASTM International, West Conshohocken, PA. All rights reserved. This material may not be reproduced or copied, in whole or in part, in any printed, mechanical, electronic, film, or other distribution and storage media, without the written consent of the publisher.

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Publisher:

ASTM International100 Barr Harbor DrivePO Box C700West Conshohocken, PA 19428-2959Phone: (610) 832-9585 Fax: (610) 832-9555ISBN 978-0-8031-7060-5ASTM Stock Number: MON06-2ND

Developed in conjunction with:American Academy of Orthopaedic Surgeons9400 West Higgins RoadRosemont, IL 60018-4976

The material presented in Bone Graft Substitutes has been made available for educational purposes only. This material is not intended to present the only, or necessarily best, methods or procedures for the medical situations discussed, but rather is intended to represent an approach, view, statement, or opinion of the author(s) or producer(s), which may be helpful to others who face similar situations.

Some drugs or medical devices described have not been cleared by the Food and Drug Administration (FDA) or have been cleared for specific uses only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice.

Furthermore, any statements about commercial products are solely the opinion(s) of the author(s) and do not represent an Academy endorsement or evaluation of these products. These statements may not be used in advertising or for any commercial purpose.

ASTM International is not responsible, as a body, for the statements and opinions advanced in the publication. ASTM International does not endorse any products represented in this publication.

Printed in Eagan, MNNovember, 2014


Dedication

To my wife Cynthia and my children Ti, Michaela, and Victoria—Cato T. Laurencin

To my wife Hua and my children Richard and Suri, with much love and thanks—Tao Jiang


THIS PUBLICATION, Bone Graft Substitutes and Bone Regenerative Engineering: 2nd Edition, was sponsored by Committee F04 on Medical and Surgical Materials and Devices. This is Monograph 6 in ASTM International’s monograph series.


Contents

Foreword vii

Preface ix

List of Contributors xi

1. Bone Graft Substitutes: Past, Present, and Future 1

2. Bone Graft Substitutes: Classifications and Orthopedic Applications 11

3. Xenograft Use in Orthopedic Surgery 41

4. Bone Grafts Based on Demineralized Bone Matrix 49

5. Clinical Perspectives on the Use of Allogenic Tissue Substitutes 73

6. Cell-Based Approaches for Bone Regeneration 97

7. Review of State of the Art: Growth Factor-Based Systems for Use as Bone Graft Substitutes 117

8. Bone Morphogenetic Proteins in Human Bone Regeneration: Successes and Challenges 167

9. Synthetic Biomimetic Porous Polymer Scaffolds for Bone Regeneration 195

10. Synthetic Bone Graft Substitutes: Basic Information for Successful Clinical Use 219

11. Bone Graft Substitutes: A Regulatory Perspective 251

12. Nanoscale Technologies for Bone Grafting 273

13. New Bone Grafting Technologies Using Stem Cells 287

14. Strategies toward Engineering Vascularized Bone Graft Substitutes 299

15. Regenerative Engineering: Fulfilling the Tissue Engineering Promise to Bone Regeneration 333

Index 367


Foreword

We are truly delighted to write the foreword for Bone Graft Substitutes and Bone Regenerative Engineering. Edited by Professor Cato Laurencin and Professor Tao Jiang, the book exemplifies the use of Convergence in the design of new technologies for bone repair and regeneration. Over the past several decades, bone grafting has been a com-mon task for orthopedic surgeons and each year millions of patients receive bone grafts worldwide. As the first generation bone grafting products, autologous bone grafts have been considered the gold standard; however, these grafts are severely lim-ited by supply. Since the late 1980s, Dr. Laurencin and others pioneered a new area of research called bone tissue engineering (BTE). BTE has gradually emerged as a prom-ising alternative to bone autografts in treatment scenarios. As such, several engineered products such as MicroFuse® have been inspired by technologies that originated in Dr. Laurencin’s laboratory. Nevertheless, various challenges in bone tissue engineering still exist, such as the need for advanced biomaterials, appropriate and reliable cell sources, and a thorough understanding of regenerative biology and tissue morphogen-esis as new technologies influencing regeneration. Therefore, many believe that Regenerative Engineering, a new field described by Dr. Laurencin with a focus on Convergence integrating biology, biomedical science, physics and engineering, serves as the future of tissue engineering. In the past decades, the Raymond and Beverly Sackler Foundation has supported and endowed numerous programs that embrace the concept of Convergence in scientific research. We are happy to have supported the creation of the Raymond and Beverly Sackler Center for Biomedical, Biological, Physical and Engineering Sciences at the University of Connecticut Health Center directed by Dr. Laurencin to support his efforts in defining the new field of Regenerative Engineering.

This timely book provides a well-rounded and articulate summary of the present status of using allogeneic, xenogenic, and synthetic bone graft substitutes to recon-struct bone tissues. Specifically, fifteen concise and comprehensive chapters are pre-pared by experts in their fields from both academia and industry. These chapters encompass numerous topics discussing the use of a wide selection of bone graft substi-tutes ranging from bone allografts and xenografts derived from human and animal tissues to synthetic biomaterials, cells, and growth factors. While many of these bone graft substitutes have experienced great clinical successes and have helped improve patients’ health, challenges still remain to reconstruct functional bone tissue mimick-ing natural bone morphogenesis. This is precisely where bone Regenerative Engineering has a niche and a significant role to play. In this regard, the book also includes a num-ber of chapters discussing frontier paradigms such as advanced materials, stem cells,


viii Foreword

nanobiotechnology, and developmental biology aiming to regenerate bone tissue in a more natural and effective way. Convergent technologies integrating the aforemen-tioned disciplines promise to continue extending research frontiers, pushing bone regeneration therapies towards a more personalized approach that can truly benefit individual patients.

This book presents an outstanding view of the subject. It will appeal to a broad audience including researchers, clinicians, and regulatory specialists in both academia and industry and will serve as a valuable resource to these professionals. We believe that this book will be a welcome addition to personal collections, libraries, and class-rooms throughout the world.

Raymond R. Sackler, MD, OBE Evan Vosburgh, MD Founder and President, Executive Director,Raymond and Beverly Sackler Foundation Raymond and Beverly Sackler Foundation


Preface

In 2003, the American Society for Testing and Materials (ASTM International) pub-lished a landmark book entitled Bone Graft Substitutes. The book was a direct result of a workshop cosponsored by ASTM International and American Academy of Orthopae-dic Surgeons (AAOS) that one of us chaired (CTL). Since the publication of the book, more than a decade has passed and the field of bone grafting has seen many dramatic changes. While the use of both autogenous and allogeneic bone grafts still remains a viable and important choice to surgeons, new technologies and strategies have gradu-ally emerged and attracted great interests from both academia and industry. Therefore, we feel that it is necessary to publish a new book that updates the trends involved with this important field.

Among the new technologies and strategies for bone regeneration, advanced materials, nanotechnology, stem cell science, and bone developmental biology are cen-tral pieces of significant research and development interests and have added to the toolbox available to biomaterials scientists and engineers to regenerate bone tissues. The convergence of these disciplines has opened a new field that we define as Regenerative Engineering. We believe that regenerative engineering is an invaluable tool and will ultimately help researchers and surgeons better regenerate individual musculoskeletal tissues and more complex organs. Successful regeneration of tissue and organ systems will rely on a multidisciplinary strategy integrating the biological principles involved in cell and developmental biology with advanced biomaterials, nanofabrication, biomechanics, and tissue engineering. To reflect on the importance of the concept of convergence, we renamed the book Bone Graft Substitutes and Bone Regenerative Engineering to capture the excitement of this new field. The chapters of the book are written by well-known researchers in academia, surgeons, industry lead-ers, and regulatory specialists. We believe that this book will be of value to people who work in all fields involving bone.

We want to acknowledge the efforts of all the contributing authors in completing this exciting project. A number of individuals who contributed to the first edition of the book have been very enthusiastic about this new book. As such, Dr. Barbara Boyan, Dr. Joseph Lane, Dr. Mark Borden, Dr. Dhirendra Katti, Dr. Yusuf Khan, Dr. Treena Arinzeh, and Dr. Sergio Gadaleta have been extremely supportive and contributed to this new work. We also want to thank Dr. Saadiq El-Amin, Dr. Steven Gitelis, Dr. Syam Nukavarapu, Dr. Jeffery Hollinger, Dr. Peter Ma, Dr. Thomas Webster, and Dr. Yunzhi Peter Yang for their fine contributions to the book and their unique perspectives on a variety of important areas on bone repair and regeneration. The publication of this book would be impossible without the assistance from numerous people at ASTM


x Preface

International. We would like to thank Dr. Michael Mitchell (Editor-in-Chief of the Journal of Testing and Evaluation), Ms. Kathy Dernoga, Ms. Heather Blasco, and Ms. Monica Siperko for their diligence, professionalism, and tremendous support in all phases during the production of the book. Finally, we thank the Raymond and Beverly Sackler Foundation for their tremendous support in our efforts to define the new field of Regenerative Engineering.

Cato T. Laurencin, M.D., Ph.D.Tao Jiang, Ph.D., M.B.A.


List of Contributors

Celeste Abjornson, Ph.D.Director, Spinal ResearchWeill Cornell Medical CollegeHospital for Special SurgeryNew York, NY

Pedro Alvarez, Ph.D.Department of Biomedical EngineeringCarnegie Mellon University,Pittsburgh, PA

Treena Livingston Arinzeh, Ph.D.Professor, Department of Biomedical

EngineeringDirector of the Graduate ProgramNew Jersey Institute of TechnologyNewark, NJ

Aditya Arora, B.E.Department of Biological Sciences and

BioengineeringIndian Institute of Technology KanpurKanpur, India

Arijit Bhattacharjee, M.S.Department of Biological Sciences and


Mark Borden, Ph.D.President/Chief Executive OfficerSynergy BiomedicalCollegeville, PA

Barbara D. Boyan, Ph.D.Dean, School of EngineeringProfessor and Goodwin Chair in Tissue

EngineeringVirginia Commonwealth UniversityRichmond, VA

David J. Cohen, M.D.Research AssociateDepartment of Biomedical EngineeringVirginia Commonwealth UniversityRichmond, VA

Brian J. Cole, M.D., M.B.A.ProfessorDepartment of OrthopaedicsDepartment of Anatomy and Cell

BiologySection Head, Cartilage Restoration

Center at RushRush University Medical CenterChicago, IL

Sita M. Damaraju, B.S.Department of Biomedical EngineeringNew Jersey Institute of TechnologyNewark, NJ

Ming Dang, M.S.Macromolecular Science and

Engineering CenterUniversity of MichiganAnn Arbor, MI


xii List of Contributors

Bruce Doll, D.D.S.Navy Medicine Research and

Development, U.S. NavyFrederick, MD

Amy Donovan, B.S.Department of Biomedical EngineeringCarnegie Mellon University,Pittsburgh, PA

Saadiq F. El-Amin III, M.D., Ph.D.Director of Shoulder and Sports

Medicine Assistant Professor, Division of

Orthopaedic Surgery Adjunct Assistant Professor Medical

Microbiology, Immunology and Cell Biology

Adjunct Assistant Professor Electric and Computer Engineering/Biomedical Engineering Program

Southern Illinois UniversitySpringfield, IL

Taj Eubanks, M.D.Division of Orthopaedics and

Rehabilitation, Department of Surgery

School of MedicineSouthern Illinois UniversitySpringfield, IL

Yale Fillingham, M.D.ResidentRush University Medical CenterChicago, IL

Rachel M. Frank, M.D.ResidentRush University Medical CenterChicago, IL

Sergio J. Gadaleta, Ph.D.Vice President, Regulatory Affairs and

Regulatory ComplianceBecton DickinsonFranklin Lakes, NJ

Steven Gitelis, M.D.Professor and Vice Chairman,

Department of Orthopaedic SurgeryDirector, Section of Orthopaedic

OncologyAssociate Chief Medical Officer for

Surgery, Chief of SurgeryRush University Medical CenterAssociate Dean of Surgical Services at

Rush Medical CollegeChicago, IL

Khadidiatou Guiro, M.S.Department of Biomedical EngineeringNew Jersey Institute of TechnologyNewark, NJ

Ashim Gupta, Ph.D.Division of Orthopaedics and


Department of Medical Microbiology, Immunology & Cell Biology

Southern Illinois UniversitySpringfield, IL

Joshua D. Harris, M.D.Rush University Medical CenterChicago, IL

Jeffrey O. Hollinger, Ph.D.Professor, Biological Sciences and

Biomedical EngineeringDirector, Bone Tissue Engineering CenterCarnegie Mellon University,Pittsburgh, PA


List of Contributors xiii

Kristen Hussey, B.S.Rush University Medical CenterChicago, IL

Tao Jiang, Ph.D., MBAAssistant ProfessorInstitute for Regenerative EngineeringDepartment of MedicineUniversity of Connecticut Health CenterFarmington, CT

Dhirendra S. Katti, Ph.D.ProfessorDepartment of Biological Sciences and


Yusuf Khan, Ph.D.Assistant ProfessorDepartment of Orthopaedic SurgeryUniversity of Connecticut Health CenterFarmington, CT

Joseph M. Lane, M.D.Assistant Dean, Hospital for Special

Surgery, Weill Cornell Medical College and affiliated hospitals

Professor of Orthopaedic Surgery, Weill Cornell Medical College

Adjunct Professor, Department of Orthopaedic Surgery, Columbia University, College of Physicians & Surgeons

Chief, Metabolic Bone Disease ServiceAttending Orthopaedic Surgeon,

Hospital for Special SurgeryNew York, NY

Cato T. Laurencin, M.D., Ph.D.University ProfessorAlbert and Wilda Van Dusen

Distinguished Professor of Orthopaedic Surgery

Professor of Chemical and Biomolecular Engineering

Professor of Materials Science and Engineering

University of ConnecticutFarmington, CT

Peter X. Ma, Ph.D.Richard H. Kingery Endowed Collegiate

Professor Professor, Department of Biologic and

Materials Sciences in the School of Dentistry

Professor, Department of Biomedical Engineering

Professor, Macromolecular Science and Engineering Center

Professor, Department of Materials Science and Engineering in the College of Engineering

University of MichiganAnn Arbor, MI

Benjamin J. MainDepartment of Medical Microbiology,

Immunology & Cell BiologySouthern Illinois UniversitySpringfield, IL

Ángel E. Mercado-Pagán, Ph.D.Postdoctoral Research FellowDepartment of Orthopaedic SurgeryStanford UniversityStanford, CA


xiv List of Contributors

Paiyz E. Mikael, M.S.Department of Materials Science and

EngineeringUniversity of ConnecticutStorrs, CT

Siyu Ni, Ph.D.Postdoctoral Research FellowDepartment of Chemical EngineeringNortheastern UniversityBoston, MA

Syam P. Nukavarapu, Ph.D.Assistant ProfessorInstitute for Regenerative EngineeringDepartment of Orthopaedic SurgeryUniversity of Connecticut Health CenterFarmington, CT

Tamara Pylawka, M.D.Division of Orthopaedics and


School of MedicineSouthern Illinois UniversitySpringfield, IL

Jennifer I. Rulka, B.S.Department of Biochemistry and

Molecular BiologyUniversity of Massachusetts AmherstAmherst, MA

Zvi Schwartz, D.M.D., Ph.D.Associate Dean for Strategic Initiatives

Professor, Department of Biomedical Engineering

Virginia Commonwealth UniversityRichmond, VA

Jae Min Shin, B.S.Department of Biologic and Materials

SciencesUniversity of MichiganAnn Arbor, MI

Arun Shrivats, Ph.D.Department of Biomedical EngineeringCarnegie Mellon University,Pittsburgh, PA

Linlin Sun, M.S.Department of Chemical Engineering,

Bioengineering ProgramNortheastern UniversityBoston, MA

James Veronick, M.S.Department of Biomedical EngineeringUniversity of ConnecticutStorrs, CT

Thomas J. Webster, Ph.D.Chair and Professor of Chemical

EngineeringNortheastern UniversityBoston, MA

Ross Wilkins, M.D.Colorado Limb ConsultantsDenver, CO

Yunzhi Peter Yang, Ph.D.Associate ProfessorDepartment of Orthopaedic SurgeryDepartment of Materials Science and

EngineeringStanford UniversityStanford, CA


Bone Graft Substitutes and Bone Regenerative Engineering 2nd Edition

EditorsCato T. Laurencin, M.D., Ph. D.Tao Jiang, Ph.D., MBA

Illustration by Philip H. Ashley, C.M.I.

ASTM INTERNATIONAL Helping our world work better

ISBN: 978-0-8031-7060-5 Stock #: MONO6-2ND

www.astm.org

LaurencinJiang

Bone G

raft Substitutes and Bone

Regenerative Engineering 2nd Edition

laurencin - astm international...regenerative engineering, a new field described by dr. laurencin...

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