Xenotransplantation research – the development of ethical guidelines

What is animal to human transplantation?

Xenotransplantation is the term used to cover the transplantation of living cells, tissues or organs from one species to another - such as from animal-to-human. Some animal materials are already used to treat humans, such as pig heart valves.  However, in these cases the tissues are chemically preserved so they contain no living cells or tissue. In contrast, xenotransplants are living cells that can perform the same functions as the organ, tissue or cells that they replace.

Animal-to-human xenotransplantation could occur in a number of ways:

  • external therapies (procedures that occur outside of the body, in which cells or fluids from the patient are filtered through or cultured (grown) with animal cells and returned to the patient)
  • cellular therapies (procedures in which cells (eg. pancreatic islet cells) from animals are transplanted or implanted into a human patient to compensate for deficient functioning of the patient’s own cells)
  • tissue transplants (procedures in which tissues (e.g. skin) from animals are transplanted or implanted into a human to replace diseased or damaged tissue)
  • organ transplants (procedures in which whole organs (e.g. a heart or kidney) are transplanted or implanted into a human patient to replace a diseased organ).

Development of the Draft Guidelines to Date

The Australian Health Ethics Committee (AHEC) has drafted a chapter on xenotransplantation research for inclusion in the National Statement on Ethical Conduct in Human Research. The draft chapter provides guidance for both researchers and Human Research Ethics Committees (HRECs), outlining institutional and researcher responsibilities and highlights ethical considerations associated with animal-to-human xenotransplantation research. 

The draft Chapter 3.6: Xenotransplantation was open for public consultation between 27 April and 8 June 2016 and 14 submissions were received. The public consultation documents, including the draft chapter and accompanying explanatory material, are available on the NHMRC consultations portal. Where permission has been granted, submissions to the public consultation will be made available from the NHMRC Public Consultation website, once the review has been completed.

The Xenotransplantation Working Committee (XWC)

The Xenotransplantation Working Committee (XWC) was established under Section 39 of the National Health and Medical Research Council Act 1992 to advise AHEC on the development of the draft chapter following public consultation. Appointments to the XWC are for the period 18 April 2016 to 30 June 2017. 

Current Activities

The XWC is in the process of considering submissions received during public consultation. The first meeting of the XWC was held in August 2016. 

Once the XWC has finalised its advice, the draft chapter will proceed to AHEC for consideration.   

Archived Publications

The following publications related to xenotransplantation are provided here for historical purposes only.

Date Publication Status
2009

Developed to assist NHMRC Council’s review of the 2004 recommendation, in December 2009.
Archived
2003

Developed by NHMRC’s Xenotransplantation Working Party for public consultation in 2003/4.
Archived
2003

Developed by NHMRC’s Xenotransplantation Working Party for public consultation in 2003/4.
Archived
2002

Developed by NHMRC’s Xenotransplantation Working Party for public consultation in 2002.
Archived

Further Information

For further information please contact NHMRC at ethics@nhmrc.gov.au.

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