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

Academic Article

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. © 2009 John Wiley & Sons A/S.
  • Authors

    Published In

    Digital Object Identifier (doi)

    Author List

  • Hering BJ; Cooper DKC; Cozzi E; Schuurman HJ; Korbutt GS; Denner J; O'Connell PJ; Vanderpool HY; Pierson RN
  • Start Page

  • 196
  • End Page

  • 202
  • Volume

  • 16
  • Issue

  • 4