The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-Executive summary

Bernhard J. Hering, David K.C. Cooper, Emanuele Cozzi, Henk Jan Schuurman, Gregory S. Korbutt, Joachim Denner, Philip J. O'Connell, Harold Y. Vanderpool, Richard N. Pierson

Research output: Contribution to journalReview articlepeer-review

77 Scopus citations

Abstract

The International Xenotransplantation Association islet xenotransplantation consensus statement describes the conditions for undertaking clinical trials of porcine islet products in type 1 diabetes. Chapter 1 reviews the key ethical requirements and progress toward the definition of an international regulatory framework for clinical trials of xenotransplantation. Chapters 2 to 7 provide in depth and agreed-upon recommendations on source pigs, pig islet product manufacturing and release testing, preclinical efficacy and complication data required to justify a clinical trial, strategies to prevent transmission of porcine endogenous retrovirus, patient selection for clinical trials, and informed consent. It is planned to update this initial consensus statement in a year's time in light of progress in research, changes in the regulatory framework, and comments submitted after publication.

Original languageEnglish (US)
Pages (from-to)196-202
Number of pages7
JournalXenotransplantation
Volume16
Issue number4
DOIs
StatePublished - Jul 2009

Fingerprint Dive into the research topics of 'The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-Executive summary'. Together they form a unique fingerprint.

Cite this