Trials Involving Animal to Human Transplants Banned

AUSTRALIA - Australia's National Health and Medical Research Council (NHMRC) today announced that clinical trials involving animal to human transplantation (xenotransplantation) would be allowed to proceed once stringent regulatory and surveillance frameworks have been put in place.
calendar icon 10 December 2009
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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, 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.

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