Abstract

Transplantation improves quality of life and saves tens of thousands of lives each year. However, the supply of human organs and tissues is insufficient to treat all patients who qualify for kidney, liver, islet cell, pancreas, heart, or lung transplantation. These considerations provide a powerful impetus motivating early clinical introduction of cross-species or “xeno” transplantation. Pigs have been developed as a potential xenograft source species based on various physiologic and logistical considerations. (1) Use of non-human primates is not feasible for a number of reasons, ethical concerns prominent among them, and because the risk of a non-human primate virus causing epidemic human disease is not acceptable. (2) Recently, a clinical islet xenograft trial involving 8 patients with diabetes and using porcine pancreatic cells has obtained provisional approval by New Zealand regulatory authorities. (3) This Commentary discusses scientific benchmarks and ethical predicates necessary prior to clinical xenotransplant trials.

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