- Xenotransplantation is the term used for the transplantation of cells, tissues or organs from one species to another (such as from pigs to humans).
- Organ xenotransplantation (eg heart, kidney) is the most well known potential procedure but the term also covers transfer of tissues and cells (eg cells from the pancreas that produce insulin). It also covers procedures that occur outside the body in which cells or fluids from the patient are cultured with or perfused through animal cells and returned to the patient.
- It was initially thought unlikely to succeed but recent advances in molecular biology and immunology have made it appear more feasible. Xenotransplantation has become a focus for transplantation research in recent years because there are not enough human organ donors to meet demand and many patients who would benefit from a transplant wait in vain for donor organs to become available.
- In addition to the NHMRC's usual extensive consultation process, for the first time, public meetings will be held in Sydney, Melbourne and Perth during August, as part of the public consultation process.
- A major thrust of current research programs involves the genetic modification of donor pigs with some key human genes so as to reduce the powerful immune response that occurs when pig tissues are transplanted into human recipients. However, a pig retrovirus has recently been identified and there are concerns that this virus may be able to cross the species barrier to humans, possibly causing a new zoonotic infection in humans.
- While acknowledging that the ethical and safety issues associated with xenotransplantation require careful consideration, most other western countries have decided to proceed with research under agreed guidelines.
- The NHMRC's Xenotransplantation Working Party believes that the best option for Australia might be to allow research to proceed cautiously under guidelines that take account of ethical issues, protect the interests of research participants, ensure that animal welfare concerns are met and safeguard public safety. However, it wishes to consult widely with the community before finalising its recommendations to the NHMRC.
- Draft guidelines have been prepared to help animal and human ethics committees to assess proposals for xenotransplantation research, particularly clinical trials. The focus of the draft guidelines is research that is directly related to the provision of xenotransplantation as a human therapy.
- The draft guidelines also encourage comment on a proposed regulatory framework for xenotransplantation.
- The draft guidelines and a discussion paper will be widely circulated and widespread debate encouraged. As for other areas of medical research, an overriding consideration for xenotransplantation research is that it should serve the common good.
Thus, while there may be differences of opinion within the community about specific ethical, practical or safety aspects of the procedures involved, the approaches taken should have overall acceptability within a broad cross-section of the community. In particular, because of the potential risk to the general public if a new infection emerges, the Australian community should be involved in decision making about whether to proceed with clinical trials.