Practical Guidelines

19.

 Bearing in mind all that has been said above, we can now present a practical approach which will guide the path of research and development in the area of xenotransplantation as applied to man.

Regarding the xenotransplantation of solid organs, it is of course necessary that pre-clinical experiments (from animal to animal) should continue for as long as scientists should require and until repeatable positive results are obtained, results which are considered sufficient to allow trials on man to begin.

When the moment arrives, it will be ethically correct, respecting the rules of informed consent indicated above, to involve initially only a restricted group of patients, patients who cannot be chosen - in the given circumstances - for allotransplantation (whether because of waiting lists or individual counter-indications), and for whom no better alternative treatment is available.

A commensurate moral imperative is that of ensuring careful and detailed monitoring of the individuals who receive a xenograft, a situation which could foreseeably continue for the rest of the patient's life, watching for any sign of possible infection caused by known and unknown pathogenic agents.

In addition, every experimental clinical trial should be carried out in highly specialised centres with proven experience in pre-clinical pig-to-primate models; these centres should be authorised and supervised by the competent health care authorities.

The results thus obtained, if unequivocally positive, would constitute the basis for extending the practice of xenotransplantation, making it an accepted surgical therapy.