The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes-- executive summary.
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.
Hering
Bernhard J
BJ
Schulze Diabetes Institute, Department of Surgery, University of Minnesota, Minneapolis, MN 55455, USA. bhering@umn.edu
Cooper
David K C
DK
Cozzi
Emanuele
E
Schuurman
Henk-Jan
HJ
Korbutt
Gregory S
GS
Denner
Joachim
J
O'Connell
Philip J
PJ
Vanderpool
Harold Y
HY
Pierson
Richard N
RN
D000818:Animals; D002986:Clinical Trials as Topic; D006801:Humans; D007258:Informed Consent; D007391:International Cooperation; D016381:Islets of Langerhans Transplantation / Q000941:ethics; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D013552:Swine; D014183:Transplantation, Heterologous / Q000941:ethics; D015047:Zoonoses