Summary media release information
NHMRC Media Team
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NHMRC has opened public consultation on draft guidelines for the ethical review and conduct of clinical trials involving animal-to-human xenotransplantation.
Xenotransplantation is the transplantation of living cells, tissues or organs from one species to another, such as from animals to humans.
Some animal materials are already used in humans, such as pig heart valves, but these are treated so they contain no living cells. In contrast, xenotransplants contain living cells that perform the same functions as the cells, tissues or organs they are intended to replace.
If research is successful, xenotransplantation could provide an alternative to the clinical use of human material. While whole organ xenotransplantation remains a distant possibility until research overcomes immunological hurdles, there has been much progress in cellular xenotransplantation.
Internationally, pre-clinical and clinical trials are investigating cellular xenotransplantation as a treatment for diseases such as type I diabetes, liver disease and neurological diseases. Ultimately, these techniques could be tested in clinical trials in Australia.
While Australia has a well-established framework for conducting clinical trials, the field of xenotransplantation poses unique public health and ethical challenges that warrant special consideration, including:
- the potential risk of diseases being transferred from animals to humans
- the need to discuss the potential risks with people in close contact with the participant, and the resulting implications for the participant’s privacy
- that participants may be unable to withdraw consent once the research has begun, since it may not be possible to remove foreign material from the body
- the need for participants to agree to life-long monitoring after the research has concluded.
The Australian Health Ethics Committee has drafted a chapter on xenotransplantation for inclusion in the National Statement on Ethical Conduct in Human Research. The draft chapter outlines institutional and researcher responsibilities, and highlights ethical considerations associated with xenotransplantation research.
NHMRC CEO, Professor Anne Kelso, acknowledged that this is a complex issue that requires consideration and input from a range of stakeholders.
“Public consultation is an important part of developing all NHMRC guidelines. I encourage all interested parties to provide comment on the draft guidelines,” she said.
The draft chapter is open for public consultation until 8 June 2016. For more information, or to make a submission, visit the
NHMRC Public Consultation website.