Consensus Statement on Conditions for Undertaking Islet Xenotransplantation Clinical Trials
IXA has worked closely with WHO and various national regulatory bodies to establish detailed recommendations regarding safe, scientifically and ethically reasonable conditions that should be met in order to undertake an islet xenotransplantation clinical trial.
The 2nd International Conference on Clinical Islet Xenotransplantation (ICCIX) took place in San Francisco on August 1, 2014. The objective of the 2nd ICCIX was to update the IXA Consensus Statement on Conditions for Undertaking Clinical Trials of Porcine Islet Products in Type 1 Diabetes, which was published in Xenotransplantation in 2009. Topics discussed included the regulatory framework, source pigs, pig islet cell products, preclinical efficacy and safety studies, recipient monitoring, patient selection, and ethical consideration. The updated IXA Consensus Statement will incorporate the current thinking of the participating opinion leaders active in the respective fields and will be published in a future issue of Xenotransplantation.