Guidelines for xenotransplantation research open for consultation

The National Health and Medical Research Council (NHMRC) has opened public consultation on draft guidelines for the ethical review and conduct of clinical trials involving xenotransplantation — the transplantation of living cells, tissues or organs from one species to another (in this case, 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.

While whole organ xenotransplantation remains a distant possibility until research overcomes immunological hurdles, there has been much progress in cellular xenotransplantation. The practice could therefore provide an alternative to the clinical use of human material.

Internationally, preclinical and clinical trials are investigating cellular xenotransplantation as a treatment for diseases such as type I diabetes, liver disease and neurological diseases. But while Australia has a well-established framework for conducting clinical trials, the field of xenotransplantation poses 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;
• 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; and
• 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, which provides guidelines for researchers, human research ethics committees (HRECs) and others conducting ethical review of research. The chapter outlines institutional and researcher responsibilities and highlights ethical considerations associated with animal-to-human xenotransplantation trials.

‘Chapter 3.6: Xenotransplantation’ is now open for public consultation. In particular, feedback is sought on whether the draft chapter:

• provides sufficient guidance to address the key ethical issues in relation to xenotransplantation research;
• provides sufficient information regarding the scope of the document; and
• is presented and written in a manner that is appropriate for the target audience (researchers, HRECs).

For more information or to make a submission, visit the NHMRC Public Consultation website. The consultation closes on 8 June at 5 pm AEST.