Australia has lifted the ban on research involving animal to human transplants.
In 2004, NHMRC recommended that there should be no animal to human transplantation (xenotransplantation) clinical trials in Australia for 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.
- 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.
In 2005, the New Zealand government recommended that xenotransplantation proceed on a case-by-case basis. Living Cell Technologies applied for approval to run a clinical trial treating eight diabetics with insulin-producing pig cells and won approval to do so earlier this year.
The SMC ran an online briefing on xenotransplantation and LCT’s trial in July. You can listen to it here.
Our colleagues at the AusSMC rounded up comment from scientists:
Dr Bob Elliott is Medical Director and Co-founder of Living Cells Technologies. Professor Elliott trained as a paediatrician at the University of Adelaide and is now based in New Zealand. Living Cell Technologies is currently conducting a trial involving xenotranplantation in New Zealand.
“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.”
Professor Jeremy Chapman, President of The Transplantation Society (An international body based out of Canada) and Clinical Professor at the University of Sydney:
“This is a very sensible and cautious approach to ensuring that Australia has a place in the developing field of xenotransplantation. The World Health Organisation and regulatory authorities around the world have defined the parameters for carefully controlled studies of transplants of cells and organs from animal origin, in the hope and expectation that they will be of substantial benefit in the future to people with serious diseases. This communique from the NHMRC provides clear guidance to researchers, to the regulatory authorities and to health care establishments and is welcomed.
Australia has a strong track record for conducting highly responsible and effective research in health care and this announcement from the NHMRC ensures that this tradition will continue.”
Professor Anthony d’Apiceis Director of the Immunology Research Centre of St Vincent’s Hospital, Melbourne. He is also former President of The Aust & NZ Transplant Society and of the International Xenotransplantation Association.
“The NHMRC Council has reversed its 2004 recommendation that prevented clinical studies in xenotransplantation being considered in Australia. Australian researchers, with the support of the NHMRC, have been and continue to be at the forefront of pre-clinical research in this area which may offer major advances for the treatment of many conditions including diabetes, and kidney, heart and liver failure. 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.
“One should not imagine that clinical trials of xenotransplantation will commence immediately, there are many steps before clinical application. Firstly there is the establishment of the regulatory framework which the NHMRC recommends be developed by the TGA and additionally there is development of monitoring and oversight procedures and formal advice for ethics committees. These will take time to develop. However the greatest hurdle will be the development of pig breeding and isolation facilities which will be expensive and whose design depends on the requirements developed by the TGA.”
Dr Dorota Pawlakis the Research Manager at the Juvenile Diabetes Research Foundation:
“JDRF fully supports the NHMRC’s decision to allow clinical xenotransplantation research in Australia. When used under strict ethical and scientific guidelines, xenotransplantation techniques have the potential to save the lives of thousands of people every year.
“This is especially true for people on organ donor waiting lists and those living type 1 diabetes. These people urgently need to replace the insulin-producing cells destoyed by the disease and there is a very real possibility that this can be done using xenotransplantation.”
For interviews with Dorota Pawlak please contact Gayle McNaught from JDRF on +61 401625905