Cord Blood

Establishing a National Hematopoietic Stem Cell Bank Program

Committee on Establishing a National Cord Blood Stem Cell Bank Program

Board on Health Sciences Policy

Emily Ann Meyer, Kathi Hanna, and Kristine Gebbie, Editors

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Cord Blood Establishing a National Hematopoietic Stem Cell Bank Program Committee on Establishing a National Cord Blood Stem Cell Bank Program Board on Health Sciences Policy Emily Ann Meyer, Kathi Hanna, and Kristine Gebbie, Editors INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by contract number HHSH25056028 between the Department of Health and Human Services and the National Academy of Sciences. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for this project. Library of Congress Cataloging-in-Publication Data Institute of Medicine (U.S.). Committee on Establishing a National Cord Blood Stem Cell Bank Program. Cord blood : establishing a national hematopoietic stem cell bank program / Committee on Establishing a National Cord Blood Stem Cell Bank Program, Board on Health Sciences Policy ; Emily Ann Meyer, Kathi Hanna, and Kristine Gebbie, editors. p. ; cm. “This study was supported by contract number HHSH25056028 between the Department of Health and Human Services and the National Academy of Sciences.” Includes bibliographical references and index. ISBN 0-309-09586-7 (hardcover)—ISBN 0-309-09644-8 1. Fetal blood—Transplantation. 2. Hematopoietic stem cells. 3. Blood banks. I. Meyer, Emily Ann. II. Hanna, Kathi E. III. Gebbie, Kristine M. IV. Title. [DNLM: 1. Cord Blood Stem Cell Transplantation—standards. 2. Blood Banks—organization & administration. 3. Blood Grouping and Crossmatching—standards. 4. Hematopoietic Stem Cell Transplantation—ethics. 5. Hematopoietic Stem Cell Transplantation—legislation & jurisprudence. 6. Hematopoietic Stem Cell Transplantation—standards. WH 380 I604c 2005] RM171.I54 2005 362.17′84—dc22 2005018345 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Cover photograph: ©M. Kulyk/Photo Researchers, Inc. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Advising the Nation. Improving Health.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program COMMITTEE ON ESTABLISHING A NATIONAL CORD BLOOD STEM CELL BANK PROGRAM KRISTINE M. GEBBIE (Chair), Associate Professor of Nursing, Columbia University, New York WADE M. AUBRY, Senior Advisor, Health Technology Center, San Francisco, California RICHARD CHAMPLIN, Chairman, Department of Blood and Marrow Transplantation, University of Texas, Houston JAMES F. CHILDRESS, Director, Institute for Practical Ethics, University of Virginia, Charlottesville CHARLES FISKE, Senior Executive, Brockton Area Multi-Services, Inc., Bridgewater, Massachusetts ROBERT D. GIBBONS, Director, Center for Health Statistics, University of Illinois at Chicago N. REBECCA HALEY, Vice President, Medical and Regulatory Affairs, StemCo Biomedical, Inc., Durham, North Carolina MARY M. HOROWITZ, Scientific Director, International Bone Marrow Transplant Registry, Medical College of Wisconsin, Milwaukee SUZANNE T. ILDSTAD, Director, Institute for Cellular Therapeutics, University of Louisville, Kentucky LINDA L. KELLEY, Director, Department of Medicine, University of Utah School of Medicine, Salt Lake City J. MICHAEL McGINNIS, Counselor to the President, The Robert Wood Johnson Foundation, Washington, DC DAVID MELTZER, Assistant Professor, General Internal Medicine, University of Chicago, Illinois KENNETH J. MOISE, JR., Professor, Obstetrics and Gynecology, University of North Carolina, Chapel Hill LARRY I. PALMER, Professor, University of Louisville, Kentucky DAVID T. SCADDEN, Director, Center for Regenerative Medicine and Technology, Massachusetts General Hospital, Boston JOHN E. WAGNER, Professor, Pediatrics, University of Minnesota, Minneapolis ANDREW M. YEAGER, Professor, School of Medicine, University of Pittsburgh, Pennsylvania IOM Project Staff Emily Ann Meyer, Study Director Shira H. Fischer, Research Associate Benjamin Hamlin, Research Associate Judith Estep, Senior Project Assistant Consultant Kathi Hanna, Science Writer/Editor

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program BOARD ON HEALTH SCIENCES POLICY PHILIP PIZZO, (Chair), Stanford University, Palo Alto, California LESLIE BENET, University of California, San Francisco DAVID BLUMENTHAL, Harvard Medical School, Boston, Massachusetts GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, Indiana ELLEN WRIGHT CLAYTON, Vanderbilt University, Nashville, Tennessee DAVID COX, Perlegen Sciences, Santa Clara, California NANCY DUBLER, Montefiore Medical Center, The Albert Einstein College of Medicine, Bronx, New York ROBERT GIBBONS, University of Illinois at Chicago LYNN R. GOLDMAN, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland BERNARD GOLDSTEIN, University of Pittsburgh, Pennsylvania MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, Maryland ALAN LESHNER, American Association for the Advancement of Science, Washington, DC DANIEL MASYS, University of California, San Diego JONATHAN MORENO, University of Virginia, Charlottesville E. ALBERT REECE, College of Medicine, University of Arkansas, Little Rock MYRL WEINBERG, National Health Council, Washington, D.C. MICHAEL J. WELCH, Washington University School of Medicine, St. Louis, Missouri MARY WOOLLEY, Research!America, Alexandria, Virginia IOM Council Liaison BERNARD LO, University of California, San Francisco IOM Board on Health Sciences Policy Staff Andrew M. Pope, Director Amy Haas, Administrative Assistant Carlos Gabriel, Financial Associate

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program INDEPENDENT REPORT REVIEWERS This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report 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 deliberative process. We wish to thank the following individuals for their review of this report: Harvey J. Alter, Department of Transfusion Medicine, National Institutes of Health, Bethesda, Maryland Fredrick R. Appelbaum, Fred Hutchinson Cancer Research Center, Seattle, Washington Ellen Areman, Division of Cell and Gene Therapies, United States Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, Maryland Mary Banfill, Michigan Community Blood Centers, Grand Rapids, Michigan Lee Ann Baxter-Lowe, University of California at San Francisco Immunogenetics Lab, San Francisco, California Ellen Wright Clayton, Genetics and Health Policy Center, Vanderbilt University, Nashville, Tennessee

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Michael F. Greene, Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts Liana Harvath, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland Armand Keating, Department of Medical Oncology and Hematology, Princess Margaret Hospital, Ontario Cancer Institute, Toronto, Ontario, Canada Eric M. Meslin, Indiana University Center for Bioethics Joana Ramos, Cancer Resources & Advocacy, Seattle, Washington Harold C. Sox, American College of Physicians of Internal Medicine, Philadelphia, Pennsylvania Mark Votruba, Department of Economics, Case Western Reserve University, Cleveland, Ohio David A. Williams, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio Charles B. Wilson, Health Technology Center, San Francisco, California Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Nancy Ascher, Professor and Chair of the Department of Surgery, University of California, San Francisco, and Enriqueta Bond, President, Burroughs Wellcome Fund, Research Triangle Park, North Carolina. Appointed by the National Research Council and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program PREFACE An effective National Cord Blood Stem Cell Bank Program should take into account current and future science; the needs of patients, physicians and donors; quality assurance; and outcomes assessment. Balancing of all these perspectives presents a substantial challenge, and tensions among current organizations active in the field led, in part, to the request for this report from the Institute of Medicine and formed a background for all of the committee’s information gathering and deliberations. The small number of extremely knowledgeable specialists in this field—many of whom have very close ties to at least one of the major participants in the organizational debate—meant that in order to ensure inclusion of all important perspectives on equity, access, and outcomes, membership on the committee changed several times. Although the changes ensured an extremely rich range of viewpoints, it may have confused some observers. The following truths regarding cord blood collection and transplantation became apparent at the first meeting and informed the committee’s discussions and recommendations throughout the study: The goal of ensuring the best care for patients requires that transplant physicians be provided with timely, complete, and accurate information on available hematopoietic stem cells from both adult donors and umbilical cord blood at the time of decision making about a transplant. Information about bone marrow donor programs and experiences had to be considered.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Quality assurance for the collection, storage, and use of cord blood is essential, as is a coordinated approach to the collection of complete information on the outcomes of all hematopoietic stem cell transplants. The committee appreciates the generosity of the many bankers, transplant physicians, transplant recipients, and scientists who shared their experiences and data during open meetings and site visits and in correspondence with the committee. Invaluable knowledge was gained, none of which could have been fully assimilated without the assistance of the very able staff supporting this report. Finally, a fully coordinated quality national system to support hematopoietic stem cell transplantation cannot be accomplished by any one action or organization. This report includes both a discussion of what such a system should look like when it is complete and focuses on the key steps that respond to immediate concerns and move toward the long-term goal. The interested community is urged to keep the goal of comprehensive support for hematopoietic stem cell transplantation in mind while struggling with the inevitably messy process of arriving at that point. The committee’s overall goal of a seamless program of access to hematopoietic stem cells points directly to a single national program encompassing the existing marrow donor programs and this cord blood program. Providing meaningful recommendations on how to accomplish such a program, however, would have required study of the existing National Marrow Donor Program and other adult hematopoietic progenitor cell programs and the ways to merge them with the specifics of a cord blood program well in excess of the time and resources available to the committee. For that reason, the report highlights the need for coordination at many points, expects analysis of outcomes from all sources of cells, leaves the door open to contractual arrangements with core components of the existing program when consistent with policy direction, and anticipates that the question of full integration will be dealt with in the future. Kristine M. Gebbie Chair

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program ACKNOWLEDGMENTS The committee wishes to acknowledge the valuable contributions that were made to this study by many individuals who shared their expertise with the committee. Special thanks go to James Burdick, Shelly Carter, Jeffrey Chell, Phil Coelho, Dennis Confer, Jeff Couglin, Michael Fitzpatrick, Captain Robert Hartzman, Liana Harvath, Valerie Hurt, Brent Jaquet, Naynes Kamani, Joanne Kurtzberg, Ellen Lazarus, David Leitch, Pam Murph, Sudip Parikh, Pablo Rubinstein, Karen Shoos-Lipton, Edward Snyder, Cladd Stevens, Susan Stewart, Phyllis Warkentin, Jill Warner, Elizabeth Wagner, and Thomas Weignand. We would also like to thank the following banks, which graciously allowed the committee to tour their facilities: CyroBanks International, New York Blood Center, Children’s Hospital Oakland, Cord Blood Registries, St. Louis Cord Blood Bank, J.P. McCarthy Cord Stem Cell Bank, and Michigan Community Blood Centers Cord Blood Bank. The committee would also like to thank the commissioned paper authors, whose contributions assisted greatly in the understanding and thorough evaluation of the subject: Karen Ballen, Robert Gibbons, Margaret Goodell, David H. Howard, and Carolyn Katovich Hurley. Thanks also go to Siddarth Puram, who worked as an intern the summer of 2004 and provided extensive help in compiling and summarizing literature and in the development and distribution of the cord blood bank survey. Finally, the committee would like to thank Philip Pizzo and the Board on Health Sciences Policy for their oversight and the IOM staff: Judy Estep,

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Shira Fischer, Benjamin Hamlin, Emily Ann Meyer, Andrew Pope, and Andrea Schultz for their support in the coordination of this project. The contributions of Kathi Hanna, who served as a consultant to the committee, are greatly appreciated.

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program CONTENTS     EXECUTIVE SUMMARY   1 1   INTRODUCTION   20 2   HEMATOPOIETIC STEM CELL TRANSPLANTATION   33 3   RESEARCH   56 4   UMBILICAL CORD BLOOD BANKS AND BANKING   75 5   ETHICAL AND LEGAL ISSUES   106 6   INVENTORY OF A NATIONAL CORD BLOOD STEM CELL BANK PROGRAM   120 7   RECOMMENDED STRUCTURE OF A NATIONAL PROGRAM   129     APPENDIXES         A  METHODS SECTION: DATA COLLECTION AND ANALYSIS   143     B  SURVEY   149     C  SURVEY RESULTS   160     D  POTENTIAL NONHEMATOPOIETIC USES FOR STEM CELLS IN CORD BLOOD   208

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program     E  A COST-BENEFIT ANALYSIS OF INCREASING CORD BLOOD INVENTORY LEVELS   221     F  HLA OVERVIEW   242     G  ANALYSIS OF THE NYBC, NMDP, AND NHLBI CORD BLOOD DATA   273     H  BIOGRAPHICAL SKETCHES OF COMMITTEE MEMBERS AND STAFF   283     ACRONYMS   293     GLOSSARY   297     INDEX   301

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program LIST OF TABLES, FIGURES, AND BOXES TABLES ES-1   Key Functions of a National Cord Blood Program,   13 1-1   Views from NYBC and NMDP on an Ideal National Stem Cell Cord Blood Bank Program,   28 2-1   Indications for Allogeneic and Autologous Stem Cell Support,   39 3-1   Genetic Diseases Treatable by Transplantation of Cord Blood,   63 3-2   Summary of Current Research,   64 4-1   Cord Blood Banking Options,   78 4-2   FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products,   93 5-1   Consent Practices for Agencies Currently Involved with Cord Blood,   108 6-1   Model of Inventory Costs,   126 7-1   Key Functions of a National Cord Blood Program, as Envisioned by the Institute of Medicine Committee,   132 C-1   Banks That Responded,   160 C-2   Type of Bank,   161 C-3   Self-Reported Accreditation,   162 C-4   Numbers of Collected, Stored, and Transplanted Units,   163 C-5   Banks Which Are Currently Collecting Units,   166 C-6   Racial Makeup of Inventory,   167

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program C-7   Criteria to Determine Which Units Are Suitable for Banking,   168 C-8   Criteria Used to Determine Which Units Are for Transplant,   172 C-9   Units That Are Not Useable for Transplant,   176 C-10   Are Units Bar Coded and Tracked Electronically? If Not, How Are They Tracked?,   177 C-11   Informatics,   178 C-12   Collection and Storage: Who Does the Collection,   179 C-13   Exclusion Criteria,   180 C-14   Screening Completed Prior to Storage,   184 C-15   Number of Units Collected and Shipped by Year,   192 C-16   Costs,   196 C-17   Funding of Public Banks,   198 C-18   Neonatal Health Status Follow-Up,   200 C-19   How the Units Are Stored,   204 D-1   Donor Cell Contribution to Nonhematopoietic Tissues After Whole Bone Marrow Transplantation in Animal Models,   210 D-2   Circulating Cell Contribution to Nonhematopoietic Tissues in Clinical Specimens,   212 E-1   Match Probabilities for Adults Age ≥20,   223 E-2   Match Probabilities for Pediatric Patients Age <20,   224 E-3   Projected Number of Annual Transplants by Cord Blood Inventory Level,   228 E-4   Life Years Gained from Marrow and Cord Transplantation,   230 E-5   Cost Model Parameters,   233 E-6   Cost Estimates by Inventory Level,   235 E-7   Cost per Life Year Gained as a Function of Cord Inventory,   236 E-8   Match Probabilities by Race,   237 E-9   Sensitivity Analysis,   238 F-1   Alleles Identified at Each HLA Locus as of January 2005,   246 F-2   DRB1*03 Allele Frequencies in Various U.S. Populations,   247 F-3   Examples of Relationships Between Serologically Defined Antigens and DNA-Defined Types,   253 F-4   Examples of Alleles Which Encode Specific HLA Proteins (or Antigens),   255 F-5   Examples of the Types of Volunteers Carrying the Same Allele, A*0201,   256 F-6   Matches for a Patient Typed a A*0201, A*3201, B*0702, B*1501, Cw*0401, Cw*0702, DRB1*0101, DRB1*0302,   259 F-7   Possible Allele Assignment of Individual Typed as 6 of 6 Antigen Match, A2, A32, B7, B62, DR1, DR3, for a Patient Typed as A*0201, A*3201, B*0702, B*1501, Cw*0401, Cw*0702, DRB1*0101, DRB1*0302,   259

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program F-8   Examples of HLA Typing Assignments Carried by Volunteer Donors on Registries,   261 F-9   Steps in Donor Selection,   262 F-10   Summary of HLA Matches at Each Locus in 6/6 Antigen Matched Donor-Recipient Pairs (n = 1422) from NMDP,   264 F-11   Summary of HLA Matches at Each Locus in 5/6 Antigen Matched Donor-Recipient Pairs (n = 429),   265 G-1   Summary Statistics Predictors by Outcomes (n = 755 Transplants),   275 G-2   Maximum Likelihood Estimates, Standard Errors, and Probabilities Main Effects Model,   277 G-3   Estimated (Observed) Cumulative Competing Risk Survival Functions Proportion Experiencing the Event,   278 G-4   Summary Statistics Cell Dose, Age, and HLA Mismatch, Number (Percent) of Patients (n = 755 Transplants),   281 FIGURES ES-1   Proposed structure of a national program,   15 2-1   Formation of the multiple peripheral blood cells from multipotent hematopoietic stem cells,   34 2-2   The human histocompatibility genes,   37 4-1   Major components in the process of cord blood collection, banking, and transplantation,   77 4-2   Example of storage container for cryopreservation of cord blood units,   84 4-3   Algorithm for selection of bone marrow versus umbilical cord blood for patients more than 20 years of age,   88 4-4   Algorithm for selection of bone marrow versus umbilical cord blood for patients less than 20 years of age,   89 7-1   The relationships that the IOM committee envisions under the governance structure described in its recommendations,   135 C-1   Total units collected, by bank,   165 C-2   Available units—across all banks,   166 C-3   Units collected and shipped, by year,   194 E-1   Search strategy for patients age ≥20,   226 E-2   Search strategy for patients age >20,   227 E-3   Total life years for 8,200 transplant candidates as a function of cord inventory,   231

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program F-1   Human histocompatibility genes,   245 G-1   Cumulative proportion alive (engrafted) (TNC/kg < 2.5 × 107),   279 G-2   Cumulative proportion alive (engrafted) (TNC/kg = 2.5 − 5.0 × 107),   280 G-3   Cumulative proportion alive (engrafted) (TNC/kg > 5.0 × 107),   281 BOXES ES-1   Summary of Recommendations for Establishing a National Cord Blood Stem Cell Bank Program,   19 2-1   HLA and HLA Matching,   36 2-2   Stratification Variables for the COBLT Study,   49 3-1   Examples of Effective Clinical Use of Cord Blood in Treating Inherited Diseases,   62 A-1   Site Visits Conducted by the Committee (by date of visit),   145

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Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program Cord Blood

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