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RR5015 Front Cover.P65 August 24, 2001 / Vol. 50 / No. RR-15 Recommendations and Reports U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Atlanta, GA 30333 Continuing Medical Education for U.S. Physicians and Nurses Inside: The MMWR series of publications is published by the Epidemiology Program Office, Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Atlanta, GA 30333. SUGGESTED CITATION Centers for Disease Control and Prevention. U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation. MMWR 2001;50(No. RR-15): [inclusive page numbers]. Centers for Disease Control and Prevention .................. Jeffrey P. Koplan, M.D., M.P.H. Director The material in this report was prepared for publication by National Center for Infectious Diseases ................................... James H. Hughes, M.D. Director This report was produced as an MMWR serial publication in Epidemiology Program Office ..................................... Stephen B. Thacker, M.D., M.Sc. Director Office of Scientific and Health Communications ........................ John W. Ward, M.D. Director Editor, MMWR Series Recommendations and Reports ................................... Suzanne M. Hewitt, M.P.A. Managing Editor ..................................................................................................... Patricia A. McGee Project Editor ......................................................................................................... Lynda G. Cupell Morie M. Higgins Visual Information Specialists ................................................................................................. Michele D. Renshaw Erica R. Shaver Information Technology Specialists Vol. 50 / No. RR-15 MMWR i Notice This report is being reprinted with the permission of the Center for Biologics Evaluation and Research, Food and Drug Administration; the Health Resources and Services Administration; the National Institutes of Health; the National Center for Infectious Diseases, Centers for Disease Control and Prevention; and the Assistant Secretary for Planning and Evalua- tion, Office of the Secretary, Department of Health and Human Services. It is reprinted as a courtesy to the MMWR readership. ii MMWR August 24, 2001 Vol. 50 / No. RR-15 MMWR iii Contents Background ........................................................................................................................ 1 Major Revisions and Clarifications to the Guideline ........................................................ 3 Definition of Xenotransplantation and Xenotransplantation Product ..................... 3 Clinical Protocol Review and Oversight .................................................................... 4 Responsibility for Design and Conduct of Clinical Protocols .................................... 4 Informed Consent and Patient Education .................................................................. 5 Deferral of Allograft and Blood Donors .................................................................... 5 Xenotransplantation Product Sources ...................................................................... 6 Source Animal Screening and Qualification ............................................................. 7 Specimen Archives and Medical Records ................................................................ 8 National Xenotransplantation Database .................................................................. 8 Secretary’s Advisory Committee on Xenotransplantation ..................................... 9 PHS Guideline on Infectious Disease Issues in Xenotransplantation ........................... 10 Introduction ...................................................................................................................... 11 Applicability .............................................................................................................. 11 Definitions ................................................................................................................. 11 Background ............................................................................................................... 13 Scope of the Document ............................................................................................ 14 Objectives ................................................................................................................. 14 Xenotransplantation Protocol Issues ............................................................................. 15 Xenotrasplantation Team ........................................................................................ 15 Clinical Xenotransplantation Site ............................................................................ 15 Clinical Protocol Review ........................................................................................... 16 Health Screening and Surveillance Plans ............................................................... 16 Informed Consent and Patient Education Processes .............................................. 16 Animal Sources for Xenotransplantation ...................................................................... 19 Animal Procurement Sources ................................................................................. 20 Source of Animal Facilities ...................................................................................... 21 Pre-xenotransplantation Screening for Known Infectious Agents ........................ 23 Herd/Colony Health Maintenance and Surveillance .............................................. 24 Individual Source Animal Screening and Qualification .......................................... 25 Procurement and Screening of Nonhuman Animal Live Cells, Tissues or Organs Used for Xenotransplantation ..................................... 27 Archives of Source Animal Medical Records and Specimens .............................. 28 Disposal of Animals and Animal By-products ........................................................ 28 Clinical Issues ................................................................................................................... 29 Xenotransplantation Product Recipient .................................................................. 29 Infection Control ....................................................................................................... 31 Health Care Records ................................................................................................ 33 Public Health Needs ........................................................................................................ 34 National Xenotransplantation Database ................................................................ 34 Biologic Specimen Archives .................................................................................... 34 Secretary’s Advisory Committee on Xenotransplantation (SACX) ...................... 34 Bibliography ..................................................................................................................... 36 Federal Laws ............................................................................................................ 36 Federal Regulations ................................................................................................. 36 Guidance Documents ............................................................................................... 36 Scientific Articles and Other Reports ...................................................................... 40 iv MMWR August 24, 2001 Vol. 50 / No. RR-15 MMWR 1 PREAMBLE U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation BACKGROUND Several developments have fueled the renewed interest in xenotransplantation — the use of live animal cells, tissues and organs in the treatment or mitigation of human disease. The world-wide, critical shortage of human organs available for transplantation and advances in genetic engineering and in the immunology and biology of organ/tissue rejection have renewed scientists’ interest in investigating xenotransplantation as a potentially promising means to treat a wide range of human disorders. This situation is highlighted by the fact that in the United States alone, 13 patients die each day waiting to receive a life-saving transplant to replace a diseased vital organ. While animal organs are proposed as an investigational alternative to human organ transplantation, xenotransplantation is also being used in the effort to treat diseases for which human organ allotransplants are not traditional therapies (e.g., epilepsy, chronic intractable pain syndromes, insulin dependent diabetes mellitus and degenerative neu- rologic diseases such as Parkinson’s disease and Huntington’s disease). At present, the majority of clinical xenotransplantation procedures utilize avascular cells or tissues rather than solid organs in large part due to the immunologic barriers that the human host presents to vascularized xenotransplantation products. However, with recent scientific advances, xenotransplantation is viewed by many researchers as having the potential for treating not only end-organ failure but also chronic debilitating diseases that affect major segments of the world population. Although the potential benefits may be considerable, the use of xenotransplantation
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