Australian Biotechnology News
Xenotransplantation trial to commence in NZ
Calls for Australian Government to lift moratorium on xenotransplantation so similar trials can occur here.

New Zealand biotechnology company, Living Cell Technologies (LCT), has announced today that it has gained approval from the New Zealand government to begin clinical trials of its DiabeCell treatment for insulin-dependent diabetes.

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, reducing or eliminating the need for insulin injections.

Because the transplanted cells are completely encapsulated and are hidden from the immune system, they don’t cause an immune rejection.

In a trial currently underway in Russia by LCT, two of seven patients are free of requiring daily insulin injections after receiving a DiabeCell implant.

The trial will take place at Middlemore Hospital in Auckland, led by Clinical Director and Diabetes Physician, Dr John Baker.

Trials in Australia are currently banned as a result of a moratorium in place by the Australian Government on xenotransplantation.

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.

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,” he said.

“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 trial allows LCT to extend its Phase I/IIa clinical data with eight patients, four of whom are to receive double the initial dose used in Russia, followed by four patients to receive triple the dose. More than 200 diabetics have already been screened to participate. The trial is expected to run for two years.

LCT CEO Dr Paul Tan said: “We are pleased that the conditions have been finalised and LCT looks forward to commencing the trial within the next two months with the acceptance of the changes by the Ethics Committee.”

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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