Content
Animal to human transplantation research (Xenotransplantation)
on this page
- » Definition: What is animal to human transplantation?
- » NHMRC's position on animal to human transplantation research
- » Frequently asked questions
- » Further information
Definition: 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 pigs to humans (ie, animal to human transplantation).
Animal to human transplantation could occur in a number of ways:
- animal 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);
- animal cellular therapies (procedures in which cells from nonhuman animal source are transplanted or implanted into a human patient to compensate for deficient functioning of the patient’s own cells); and
- whole animal organ transplants (procedures in which whole organs (eg a heart, kidney) or tissues (eg skin) from a nonhuman animal source are transplanted or implanted into a human patient to replace a diseased organ).
[top]
The NHMRC's position on animal to human transplantation research
On 9 December 2009, the Council of the NHMRC recommended that clinical trials involving animal to human transplantation (xenotransplantation) only be allowed to proceed when the following conditions are in place:
- The Therapeutic Goods Administration has implemented a robust framework to regulate clinical trials involving xenotransplantation;
- A robust standard of oversight and monitoring is established, including for example, a surveillance strategy and a patient register; and
- The NHMRC has issued, using the advice of its Australian Health Ethics Committee and Animal Welfare Committee, guidance for researchers and ethics committees involved in animal to human studies.
The decision does not permit animal to human transplantation to be used as a routine treatment for diseases.
[top]
How was the recommendation made?
In December 2004, NHMRC recommended that there be no xenotransplantation clinical trials in Australia for five years. The recommendation was made on the basis that risks of transmission of animal viruses to transplant recipients and the wider community had not been adequately resolved, and that xenotransplantation research was at an early stage and clinical trials in the foreseeable future were unlikely to be of significant benefit to research participants.
Since its recommendation on xenotransplantation in 2004, NHMRC has been monitoring developments in science and technology, in particular, evidence relating to the risks of transmission of animal viruses to humans.
NHMRC’s Council was asked to consider the issues pertinent to clinical trials involving xenotransplantation and determine at its 180th session, in December 2009, whether there is a need to continue with the recommendation made in 2004.
NHMRC’s Council assessed the risks and benefits of clinical trials with a particular focus on the scientific and technical developments in xenotransplantation research over the last five years and concluded that although there are differences of opinion in the community regarding the acceptability of xenotransplantation, the research could proceed in Australia when appropriate regulatory and surveillance frameworks (as described above) have been put in place.
[top]
Current activities
NHMRC will now develop guidance for researchers and ethics committees involved in animal to human studies and work in collaboration with the Health Portfolio to determine what additional requirements are necessary to ensure a robust standard of oversight and monitoring.
NHMRC will undertake community consultation when developing guidance documents.
Frequently asked questions
For more information on animal to human transplantation see our answers to frequently asked questions (FAQs) about xenotransplantation.
» See more information on the FAQs
[top]
Further information
Public Consultation Documents:
The Xenotransplantation Working Party developed the following document to inform the first round of public consultation in 2002.
» Download: Draft guidelines and discussion paper on xenotransplantation (PDF, 774kb) 
The feedback received from the 2002 public consultation highlighted a need to clarify the meaning of animal to human transplantation research to the Australian community and in particular, the differences between the three types of animal to human transplantation. Subsequently, the Xenotransplantation Working Committee developed two further documents.
The first document (Animal to human transplantation research: How should Australia proceed?) is the Xenotransplantation Working Committee’s response to the 2002 public consultation on Draft guidelines and Discussion Paper on xenotransplantation.
The second paper (Animal to human transplantation research: A guide for the community) complements the first document by providing background information on animal to human transplantation. It defines xenotransplantation and explains what animal to human transplantation research involves. Furthermore it discusses why such research is being considered in Australia and considers the issues of ethics, risk and animal welfare.
» Download: Animal to human transplantation research: How should Australia proceed? (PDF, 1119kb)
» Download: Animal to human transplantation research: A guide for the community (PDF, 147kb)
Help
|
Linked documents tagged with the PDF icon Note: Attempting to open large PDF files within the browser window may lead to system problems. For more information see Troubleshooting and access of large pdf documents. |