Clinical Xenotransplantation

David K.C. Cooper MD, PhD, FRCSUniversity of Alabama at Birmingham (UAB)Co-Director, Xenotransplantation ProgramDepartment of SurgeryBirmingham, AL Guerard W. Byrne, PhDDepartment of SurgeryUniversity of Alabama at BirminghamBirmingham, ALUSA

• Clinical and Experimental Xenotransplantation: Background.- 1. A brief history of clinical cross-species organ xenotransplantation.- 2. The pathobiology of pig-to-primate xenotransplantation: a historical review.- 3. Is sensitization to pig antigens detrimental to subsequent allotransplantation?.- 4. Sensitization to human leukocyte antigens and xenotransplantation?.- Pig Kidney and Heart Xenotransplantation in Nonhuman Primates – the Present Position.- 5. Kidney xenotransplantation in nonhuman primates.- 6. Cardiac xenotransplantation in nonhuman primates.- Organ-source Pig Genetic Engineering and Regulation.- 7. Gene-edited pigs for xenotransplantation.- 8. Addressing regulatory requirements for the organ-source pig – a pragmatic approach to facility design and pathogen prevention.- Antibody-Mediated Allotransplant Rejection: Lessons for Xenotransplantation.- 9. Antibody-mediated graft rejection in nonhuman primate models: comparison of sensitized allotransplant and xenotransplant rejection.- 10. Management of anti-HLA antibodies and acute antibody-mediated rejection.- 11. Evolving approaches to treatment of allosensitization and antibody-mediated rejection.- 12. Lessons from ABO-incompatible cardiac allotransplantation in the newborn.- Patient Evaluation and Selection for First Clinical Trials of Kidney or Heart Xenotransplantation.- 13. Defining an “acceptable risk threshold” – who should be the first kidney xenotransplant recipient?.- 14. Selection of patients for initial clinical trials of kidney xenotransplantation.- 15. Selection of patients for initial clinical trials of cardiac xenotransplantation.- 16. Selection of pediatric patients for initial clinical trials of cardiac xenotransplantation.- 17. Infection in xenotransplantation: organ-source health and patient safety.- 18. Histocompatibility testing for xenotransplantation.- Regulatory, Economic, and Social Aspects of Clinical Trials of Xenotransplantation.- 19. Xenotransplantation; the FDA perspective.- 20. Xenotransplantation: a payer’s perspective.- 21. Public perceptions towards clinical trials of organ xenotransplantation.- Summation.- 22. What did the workshop achieve?