MEDIA RELEASE
Clinical trials involving animal to human transplantation
Date: Thursday 10 December, 2009
The National Health and Medical Research Council (NHMRC) today announced that clinical trials
involving animal to human transplantation (xenotransplantation) would be allowed to proceed, when
stringent regulatory and surveillance frameworks have been put in place.
NHMRC Chairman, Professor Michael Good AO, said the Council, in making its recommendation, had
noted the developments in science and technology since 2004, in particular evidence relating to the risks of
transmission of animal viruses.
“After careful consideration, the Council is of the view that, although there is a wide range of community
views on the topic, xenotransplanation research was acceptable in Australia when there are robust
regulations in place,” Professor Good said.
“Council has taken into account a range of issues including the risk of viral transmission and the evidence
available on the safety of the therapy for individuals and the wider community.”
NHMRC CEO, Professor Warwick Anderson AM, said as with other medical technologies, the process for
testing new procedures through clinical trials can take many years and involve several phases.
“Trials would be able to proceed once ethical approval has been given and the Therapeutic Goods
Administration has implemented a robust framework to regulate clinical trials involving
xenotransplantation,” Professor Anderson said.
“Further the NHMRC, using the advice of its Australian Health Ethics Committee and Animal Welfare
Committee, the NHMRC would now develop guidance for researchers and ethics committees involved in
animal-to-human studies.
“The NHMRC will also work with the Australian Government’s Department of Health and Ageing (DoHA)
to determine appropriate surveillance and monitoring frameworks to support clinical trials going forward.”
International experience has largely been in the area of using insulin-producing cells from a pig pancreas to
treat a person with type 1 diabetes.
Contact: Simon Tidy, NHMRC, (02) 6217 9190 / 0422 008 512
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