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.
Schulze Diabetes Institute, Department of Surgery, University of Minnesota, Minneapolis, MN 55455, USA. bhering@umn.edu
Bernhard J
BJ
Hering
David K C
DK
Cooper
Emanuele
E
Cozzi
Henk-Jan
HJ
Schuurman
Gregory S
GS
Korbutt
Joachim
J
Denner
Philip J
PJ
O'Connell
Harold Y
HY
Vanderpool
Richard N
RN
Pierson
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