First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes—Chapter 4: pre‐clinical efficacy and complication data required to justify a clinical trial

• DOI: 10.1111/xen.12226
• Publication Date: 2016-02-26T08:51:46Z
• Authors: David K.C. Cooper; Rita Bottino; Pierre Gianello; Melanie Graham; Wayne J. Hawthorne; Allan D. Kirk; Olle Korsgren; Chung‐Gyu Park; Collin Weber
• Keywords: Xenotransplantation

Abstract In 2009, the International Xenotransplantation Association ( IXA ) published a consensus document that provided guidelines and “recommendations” not regulations) for those contemplating clinical trials of porcine islet transplantation. These included 's opinion on what constituted “rigorous pre‐clinical studies using most relevant animal models” were based “non‐human primate testing.” We now report our discussion following careful review 2009 as they relate to testing. summary, we do believe there is need greatly modify conclusions recommendations original document. Pre‐clinical should be sufficiently rigorous provide optimism trial likely safe has realistic chance success, but so demanding success might only achieved by very prolonged experimentation, this would in interests patients whose quality life benefit immensely from successful xenotransplant. these will both investigators planning institutions regulatory authorities considering proposal trial. addition, suggest consideration given establishing an Clinical Trial Advisory Committee available advise (but regulate) researchers initiating xenotransplantation.