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Australia lifts ban on trials for animal-to-human transplants
AUSTRALIA announced yesterday it will lift a five-year ban on clinical trials of animal-to-human transplantation, after the government's top health body determined the risk of transmitting animal viruses to people was low.
The decision by the National Health and Medical Research Council means Australia will join a slew of other countries, including the United States and New Zealand, that have conducted trials of xenotransplantation, the transfer of living cells, tissues or organs from one species to another.
Xenotransplantation researchers hope the procedure can someday serve as a substitute for human organs, which are in chronic short supply, and help treat diseases such as diabetes and Parkinson's.
The council issued a ban on clinical trials in 2004, after concerns were raised about the risks of transmitting animal viruses - particularly those from pigs - to humans.
Yesterday, the council said in a statement it was satisfied such risks were low and that trials should be allowed to proceed once strict regulatory and surveillance frameworks are put in place. The council plans to consult the Australian Health Ethics Committee and Animal Welfare Committee to develop guidance for researchers and ethics committees involved in animal-to-human studies.
The council's decision is long overdue, said Anthony d'Apice, director of the Immunology Research Center at St Vincent's Hospital in Melbourne, and past president of the Transplant Society of Australia and New Zealand and the International Xenotransplant Association. "Everything in medicine contains risks - having your tonsils out or taking an antibiotic - it all involves risk," he said. "It's a matter of risk versus benefit analysis. And the risks are assessed as being small and the potential benefits great."
The move was also welcomed by Australian biotech company Living Cell Technologies, which is conducting a trial in New Zealand that implants cells from newborn pigs into human volunteers as an experimental treatment for diabetes.
The cells produce pig insulin, which is very similar to human insulin and has the same effect of lowering blood sugar, and Living Cell Technologies hopes the cells may be able to delay the effects of Type 1 diabetes - including blindness, premature coronary illness and limb amputation caused by poor blood circulation.
The decision by the National Health and Medical Research Council means Australia will join a slew of other countries, including the United States and New Zealand, that have conducted trials of xenotransplantation, the transfer of living cells, tissues or organs from one species to another.
Xenotransplantation researchers hope the procedure can someday serve as a substitute for human organs, which are in chronic short supply, and help treat diseases such as diabetes and Parkinson's.
The council issued a ban on clinical trials in 2004, after concerns were raised about the risks of transmitting animal viruses - particularly those from pigs - to humans.
Yesterday, the council said in a statement it was satisfied such risks were low and that trials should be allowed to proceed once strict regulatory and surveillance frameworks are put in place. The council plans to consult the Australian Health Ethics Committee and Animal Welfare Committee to develop guidance for researchers and ethics committees involved in animal-to-human studies.
The council's decision is long overdue, said Anthony d'Apice, director of the Immunology Research Center at St Vincent's Hospital in Melbourne, and past president of the Transplant Society of Australia and New Zealand and the International Xenotransplant Association. "Everything in medicine contains risks - having your tonsils out or taking an antibiotic - it all involves risk," he said. "It's a matter of risk versus benefit analysis. And the risks are assessed as being small and the potential benefits great."
The move was also welcomed by Australian biotech company Living Cell Technologies, which is conducting a trial in New Zealand that implants cells from newborn pigs into human volunteers as an experimental treatment for diabetes.
The cells produce pig insulin, which is very similar to human insulin and has the same effect of lowering blood sugar, and Living Cell Technologies hopes the cells may be able to delay the effects of Type 1 diabetes - including blindness, premature coronary illness and limb amputation caused by poor blood circulation.
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