The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes Chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework

Mariachiara Tallacchini, Emanuele Cozzi, Enda B. Flanagan, Richard N. Pierson Iii, Megan Sykes, Harold Y. Vanderpool

Risultato della ricerca: Contributo in rivistaArticolo in rivistapeer review

31 Citazioni (Scopus)

Abstract

The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate.
Lingua originaleEnglish
pagine (da-a)203-214
Numero di pagine12
RivistaXenotransplantation
Volume16
Stato di pubblicazionePubblicato - 2009

Keywords

  • ethics
  • regulation
  • xenotransplantation

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