Australia has lifted the ban on research involving animal to human transplants. In 2004, National Health and Medical Research Council (NHMRC) recommended that there should be no animal to human transplantation (xenotransplantation) clinical trials in Australia for a period of five years, subject to review in December 2009.
The NHMRC Council has now recommended that xenotransplantation research could proceed in Australia 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
- 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.
However, experts have noted that Australia is already lagging behind many other countries in this field of research and will have some catching up to do. Professor Anthony d’Apice, Director of the Immunology Research Centre of St Vincent's Hospital, Melbourne, observes that “Over the last 5 years the world has moved forward, not by conducting clinical trials but in developing the guidelines and processes necessary to ensure that clinical trials are conducted safely. Australia must now catch up and establish the regulatory frameworks which the NHMRC notes as necessary prerequisites and which are now in place in many developed nations, including New Zealand where a clinical trial is already underway.”
To wit, Dr Bob Elliott the Medical Director of Living Cells Technology who is currently conducting a trial involving xenotranplantation in New Zealand, made the following comment:
“We welcome this decision. It is a good response to the way the science has moved. The fears concerning infections from the animals have receded at the same time as the likelihood of benefit arising from the use of cellular animal tech products increases. It has always been a matter of balance between potential risk and potential benefit and I think the equation now has tipped in favor of the benefit being well worth any theoretical risk. We welcome the change it will allow us to apply for a clinical trial in Australia, which we will do quite quickly. It opens the door for us being able to get on and try some of the other cell types we have been planning. So it is good, not just for diabetes, but for other diseases too, for example the one we are targeting at the moment is Parkinson’s disease.”
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