Clinical Trials Involving Animal To Human Transplantation

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10th December 2009, 02:23pm - Views: 1082

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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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