Clinical trial raises hope for Australian diabetics to be insulin free

Jun 23 2009

A clinical trial for a new treatment for type 1 diabetes which potentially eliminates the need for daily insulin injections will commence in New Zealand by Australian company Living Cell Technologies (LCT).

In a trial currently underway in Russia by LCT, two patients are free of requiring daily insulin injections after receiving a Diabecell implant. However, Australian diabetics will have to wait as a result of a moratorium in place by the Australian Government on the technology behind Diabecell.

Diabecell are pig cells that produce insulin and when implanted into the abdomen have been shown to lead to near-normal blood glucose levels in patients and the need for insulin injections to be reduced or eliminated.

The Australian Government imposed a five year moratorium on xenotransplantation in 2004, prohibiting the transplantation of organs or cells from animals to humans until more information is available about possible health risks. The moratorium is similar to restrictions placed on stem cell research in Australia, an area now well recognized as being essential to future health management. A clear benefit of LCT's technology is that the cells are completely encapsulated and are hidden from the immune system and therefore don't cause an immune rejection.

In light of the compelling results on diabetics participating in trials elsewhere in the world, Australian doctors are now calling for the Australian government to review its position on the moratorium.

Professor John Dwyer, Clinical Immunologist and Emeritus Professor at the University of New South Wales said the start of the New Zealand diabetes trial marks an important development for the Australian scientific and medical community.

"The safe transplantation of insulin producing cells would offer us by far the best technique for controlling diabetes in millions of sufferers globally. These clinical trials are essential as there is no other way of studying the potential benefits except by transplanting these cells into humans."

"This technique has enormous potential to reduce suffering and the enormous costs involved in treating diabetes and its many complications. The approval of this trial in New Zealand will hopefully lead to a reconsideration of the current moratorium on xenotransplantation in Australia. Given the safety data now available I am convinced the Australian Government should lift its ban on Australian clinical researchers doing similar trials. We have many leaders in the field in Australia ready to contribute to the global effort to cure diabetes," Professor Dwyer said.

The New Zealand Health Minister, the Honourable Tony Ryall, announced today his approval for the Diabecell trial to commence at the Middlemore Hospital, Auckland, immediately. More than 200 diabetics have already been screened to participate, with LCT aiming to involve eight people on the trial which is expect to run for two years.

Founder of LCT and diabetes specialist Prof. Bob Elliott said: "We have great hopes for these trials. We already have two patients in the Russian trials that are now off insulin and we are planning to use much higher doses of our product Diabecell in these trials."

"Whilst the trials of Diabecell are on our doorstep, Australians will not be able to participate in them because of a current moratorium banning this type of research. We hope that the Australian government will now review its position on our technology and have renewed confidence of the potential value of Diabecell in significantly improving the lives of people living with diabetes."

According to the International Diabetes Federation, there are currently around 890,000 Australians who suffer from type 1 and type 2 diabetes, with an additional 3.2 million Australians living with pre-diabetes.

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