Proceeding with clinical trials of animal to human organ transplantation: a way out of the dilemma

Abstract

The transplantation of porcine organs to humans could in the future be a solution to the worldwide organ shortage, but is to date still highly experimental. Further research on the potential effects of crossing the species barrier is essential before clinical application is acceptable. However, many crucial questions on efficacy and safety will ultimately only be answered by well designed and controlled solid organ xenotransplantation trials on humans. This paper is concerned with the question under which conditions, given the risks involved and the ethical issues raised, such clinical trials should be resumed. An alternative means of overcoming the safety and ethical issues is suggested: willed body donation for scientific research in the case of permanent vegetative status. This paper argues that conducting trials on such bodies with prior consent is preferable to the use of human subjects without lack of brain function

Islet Xeno/transplantation and the risk of contagion: local responses from Canada and Australia to an emerging global technoscience

“…Xenotransplantation is ‘the practice of transplanting, implanting or infusing cells, tissues or organs from one species to another’ (Ravelingien et al 2002 , 92). It may involve internal or external xenogenic therapies 1 designed as a temporary bridging device or as a ‘final solution to end-stage organ failure’ (Boneva and Folks 2004 , 504).…”

Xenotransplantation, Consent and International Justice

“…11 There is also the risk that any such infection may prove contagious and spread to affect other members of the community. 17 It has been suggested that the source animals for transplants could be bred and raised in isolation from other animals so as to be disease-free. 12 There is also some evidence that this change has been brought about by animals of different species being brought into regular, close proximity as a result of human agricultural practices.…”

“…16 Researchers are also developing techniques to try to eliminate or at least reduce them. 17 It has been suggested that the source animals for transplants could be bred and raised in isolation from other animals so as to be disease-free. 18 Unfortunately, this technique will not protect recipients from infection by agents they come into contact with after the operation, nor will it eliminate the risk posed by the existence of porcine endogenous retroviruses (PERVs), which are present in the genetic code of the cells of all pigs.…”

Xenotransplantation: a bioethical evaluation

“…1 Such monitoring may even be extended to the sexual partners, friends, and family of recipients. 9 Mandatory surveillance such as this is ethically controversial, as doing this violates rights to individual privacy. Precedents, such as the Declaration of Helsinki and the Nuremberg trials declaration, ensure that participation in studies is entirely voluntary, not hurried, and exit from the study is the autonomous decision of each participant.…”