title: Justifying clinical trials for porcine islet xenotransplantation.
abstract: The development of the Edmonton Protocol encouraged a great deal of optimism that a cell-based cure for type I diabetes could be achieved. However, donor organ shortages prevent islet transplantation from being a widespread solution as the supply cannot possibly equal the demand. Porcine islet xenotransplantation has the potential to address these shortages, and recent preclinical and clinical trials show promising scientific support. Consequently, it is important to consider whether the current science meets the ethical requirements for moving toward clinical trials. Despite the potential risks and the scientific unknowns that remain to be investigated, there is optimism regarding the xenotransplantation of some types of tissue, and enough evidence has been gathered to ethically justify clinical trials for the most safe and advanced area of research, porcine islet transplantation. Researchers must make a concerted effort to maintain a positive image for xenotransplantation, as a few well-publicized failed trials could irrevocably damage public perception of xenotransplantation. Because all of society carries the burden of risk, it is important that the public be involved in the decision to proceed. As new information from preclinical and clinical trials develops, policy decisions should be frequently updated. If at any point evidence shows that islet xenotransplantation is unsafe, then clinical trials will no longer be justified and they should be halted. However, as of now, the expected benefit of an unlimited supply of islets, combined with adequate informed consent, justifies clinical trials for islet xenotransplantation.
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, AB, Canada.|Alberta Diabetes Institute, University of Alberta, Edmonton, AB, Canada.
authors.forename: Cara E
authors.initials: CE
authors.lastname: Ellis
authors.affiliation: Department of Surgery, University of Alberta, Edmonton, AB, Canada.|Alberta Diabetes Institute, University of Alberta, Edmonton, AB, Canada.
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Korbutt
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000941:ethics*; D003922:Diabetes Mellitus, Type 1 / Q000601:surgery*; D006801:Humans; D016381:Islets of Langerhans Transplantation / Q000941:ethics / Q000379:methods*; D013552:Swine; D014183:Transplantation, Heterologous / Q000941:ethics*
keywords: clinical trials; diabetes; islet transplantation; public health policy; xenotransplantation