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Neural Grafting: Repairing the Brain and Spinal Cord

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Neural Grafting: Repairing the Brain and Spinal Cord Neural Grafting: Repairing the Brain and Spinal Cord October 1990 OTA-BA-462 NTIS order #PB91-114249 Recommended Citation: U.S. Congress, Office of Technology Assessment, Neural Grafting: Repairing the Brain and Spinal Cord, OTA-BA-462 (Washington, DC: U.S. Government Printing Office, September 1990. For sale by the Superintendent of Documents U.S. Government Printing Office, Washington, DC 20402-9325 (order form can be found in the back of this report) Foreword Extraordinary developments in the neuroscience in recent years have shown promise of new advances for treating diseases of the nervous system and for increased general understanding of the human mind. Paralleling these developments has been a growing congressional interest in their policy implications. The designation of the 1990s by the101st Congress as the “Decade of the Brain” is one indication of this interest, as was the request for OTA to undertake a series of reports under an assessment of “New Developments in Neuroscience.” Requesting committees are the House Committees on Energy and Commerce; Science, Space, and Technology; Appropriations; Veterans Affairs; and the Senate Subcommittee on Science, Technology, and Space of the Committee on Commerce, Science, and Transportation. This special report, the second of our neuroscience series, discusses the field of neural grafting into the brain and spinal cord to treat neurological disorders. It describes the technology of neural grafting, the neurological conditions that it may be used to treat, and the patient populations that are affected. Also, the legal and ethical issues raised by the development of neural grafting techniques are discussed. The report includes a range of options for congressional action related to the Federal funding of transplantation research using human fetal tissue, the adequacy of existing Federal laws and regulations regarding the use of human fetal tissue, and the role of the Federal Government in guiding the development and promoting the safety and efficacy of neural grafting procedures. The first publication in OTA’s assessment of “New Developments in Neuroscience” was Neurotoxicity: Identifying and Controlling Poisons of the Nervous System, published in April 1990. OTA was assisted in preparing the present study by a panel of advisers, a workshop group, and reviewers selected for their expertise and diverse points of view on the issues covered by the assessment. OTA gratefully acknowledges the contribution of each of these individuals. As with all OTA reports, responsibility for the content of the report is OTA’S alone. A.-# A. KJOHN YH. GIBBONS u Director . Ill New Developments in Neuroscience Advisory Panel Peter S. Spencer, Chair Center for Research, Occupational, and Environmental Toxicology Oregon Health Sciences University Portland, OR Robert H. Blank Laurane G. Mendelssohn Social Science Research Institute Manager of Personnel Research Northern Illinois University Lilly Research Laboratories DeKalb, IL Indianapolis, IN James F. Childress Franklin E. Mirer Department of Religious Studies Director, Health and Safety Department University of Virginia United Auto Workers Charlottesville, VA Detroit, MI Fred H. Gage Albert S. Moraczewski Department of Neuroscience Regional Director University of California-San Diego Pope John XXIII Medical, Moral, Research, La Jolla, CA and Education Center Houston, TX Bernice Grafstein Department of Physiology Herbert Paroles Cornell University Department of Psychiatry New York, NY Columbia University New York NY Ronald Kartzinel Vice President for CNS Development Richard M. Restak CIBA-GEIGY Corporation Physician Summit, NJ Neurological Associates, P.C. Washington, DC Alan Kraut Executive Director American Psychological Society Washington, DC Neural Grafts Study Panel Roy A. E. Bakay Mary B. Mahowald Section of Neurosurgery Center for Clinical Medical Ethics The Emory Clinic University of Chicago Atlanta, GA Chicago, 11 Nancy Buc (ad hoc) Jerry Silver Partner Department of Developmental Genetics Weil, Gotshal & Manges Case Western Reserve Univ. Washington, DC Cleveland, OH Robert P. Gale John R. Sladek, Jr. Division of Hematology and Oncology Department of Neurobiology and Anatomy University of California-Los Angeles University of Rochester Los Angeles, CA Rochester, NY Patricia King (ad hoc) H.Fred Voss Georgetown University Program Director Law Center Biotrack, Inc. Washington, DC Mountain View, CA NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the advisory and study panel members. The panels do not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy of its contents. iv OTA Project Staff-Neural Grafting: Repairing the Brain and Spinal Cord Roger C. Herdman, Assistant Director, OTA, Health and Life Sciences Division Gretchen S. Kolsrud, Biological Applications Program Managerl OTA Project Staff David R. Liskowsky, Project Director Timothy P. Condon, Project Director2 Monica Bhattacharyya, Research Assistant Joyce Anne Brentley, Legal Analyst Laura Lee Hall, Analyst Wendy S. Pachter, Legal Analyst Claire L. Pouncey, Research Assistant E. Blair Wardenburg, Research Analyst3 Gladys B. White, Analyst 4 Patricia Anderson, NIH Detailees Support Staff Cecile Parker, Office Administrator Linda Rayford-Journiette, Administrative Secretary Jene Lewis, Secretary Sharon Oatman, Administrative Assistant6 Contractors Blair Burns Potter (editor), Bethesda, MD Julie Phillips (indexer), Oakton, VA Lori Andrews, American Bar Foundation Alan Fine, Dalhousie University Thomas B. Freeman, University of South Florida Karen Gervais, University of Minnesota Center for Biomedical Ethics William F. Hickey, Washington University Ronald D. McKay, Massachusetts Institute of Technology Rosa Lynn Pinkus, University of Pittsburgh Ali H. Rajput, University of Saskatchewan Imou@ September 1989 2mou@ August 1989. 3~ou@ August 1989. 4 Through June 1989. 5 Through October 1989. 6 Through February 1989. Contents Page Chapter 1: Summary, Policy Issues, and Options for Congressional Action . 3 Chapter 2: Introduction ... ... ... ... ... ... ... ... .*. ... .*. ... .$. .*. .$. **@"$"""""""" 19 Chapter 3: Neuroscience Primer . 29 Chapter 4: General Features of Neural Grafting . 39 Chapter 5: Applications of Neural Grafting Into the Brain and Spinal Cord . 61 Chapter 6: Relevant Neurological Disorders . 93 Chapter 7: Legal and Regulatory Issues . 113 Chapter 8: Ethical Issues . 149 Appendix A: DHHS Moratorium on Human Fetal Tissue Transplantation Research . 171 Appendix B: Participants in the Workshop on New Developments in Spinal Cord Injury: Acute Interventions and Neural Grafts . 174 Appendix C: Decade of the Brain . 175 Appendix D: Acknowledgments . 177 Appendix E: List of Contractor Documents . 180 Appendix F: Acronyms and Glossary of Terms . 181 Index . .187 Chapter 1 Summary, Policy Issues, and Issues for Congressional Action CONTENTS Page GENERAL FEATURES OF THE NERVOUS SYSTEM AND NEURAL GRAFTING . .’. 4 Therapeutic Strategies ... ... ... ... ... ... ..*. o..........*..*....***.*.*+..******* 4 Materials for Neural Grafting . 4 Determinants of Successful Neural Grafting . 5 Potential Risks . 5 APPLICATIONS OF NEURAL GRAFTING INTO THE BRAIN AND SPINAL CORD . .. 5 RELEVANT NEUROLOGICAL DISORDERS . .. 7 LEGAL AND REGULATORY ISSUES . 7 Protection of Neural Graft Recipients . 8 Protection of Donors of Fetal Tissue . 8 Government Oversight . 9 ETHICAL ISSUES . 9 POLICY ISSUES AND OPTIONS FOR CONGRESSIONAL ACTION . 11 Figures Figure Page 1-1. Components of the Nervous System . 5 1-2. Methods Used To Graft Genetically Modified Cells . ......,..........*.**,..*,,. 6 1-3. National Institutes of Health 1989 Estimates of Costs of Neurological Disorders . 7 Tables Table Page 1-1. Prevalence of Neurological Disorders in the United States . 3 1-2. Federal Funding of Neural Grafting Research . 4 Chapter 1 Summary, Policy Issues, and Options for Congressional Action Tens of millions of Americans suffer from some mechanisms of neurological injury and disease. For form of neurological disorder. Some of these most neurological disorders, current treatments do disorders are minor and are easily treated with not provide a cure, but rather relief of symptoms. It medication or rest. Others are marked by severe, is possible that neural grafting could provide a cure debilitating symptoms and result in pain, suffering, in some cases where current treatments cannot (e.g., and sometimes death. Some neurological disorders injury) or could bring about sustained relief from may be treatable by neural grafting—i.e., the symptoms where existing therapies either fail or lose transplantation of tissue into the brain and spinal their effectiveness (e.g., certain diseases, such as cord (table l-l). Although few neural grafting Parkinson’s). Because of this potential, transplanta- procedures have been carried out to date, the number tion of tissue into the central nervous system (CNS) could increase in the future. may become a significant therapeutic alternative in the future. Neural grafting has long been used in basic research to study the nervous system. In fact, much neural grafting continues to be used as a tool for Currently, grafting of tissue into the CNS to understanding the development of the nervous treat neurological disorders is highly experimen- system and its response to injury. In addition to its tal. Neural grafting has advanced to clinical human use as a research
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