LCT diabetes technology makes debut in Italian trial

Italian researchers have transplanted insulin-secreting pancreatic islet cells into a 37-year old man with type 1 diabetes, in the first of a 10-patient pilot trial of a potentially revolutionary treatment for diabetes developed by Australian biomedical company Living Cell Technologies (NSX:LCT).

The living islet cells are encapsulated in a natural, biocompatible polymer -- alginate, extracted from seaweed. The alginate provides an impermeable barrier to immune-system cells that would rapidly destroy the islet cells, avoiding the need to use powerful and costly immunosuppressant drugs.

But while it excludes immune-system cells, the alginate capsule remains permeable both to glucose and insulin. The transplanted cells are able to 'read' fluctuating blood glucose levels and match their insulin production to the body's normal requirements.

Conventional insulin injections deliver a bolus dose, and patients can veer between hypoglycaemia and hyperglycaemia. Poor control over insulin levels can have long-term side-effects including blindness and tissue necrosis in fingers and toes.

LCT has been collaborating with a team of Italian researchers from University of Perugia and the Policlinico 'Umberto 1' in Rome.

The first trial procedure, sanctioned by the Italian Institute of Health, employed encapsulated islet cells from a human donor. The cells were introduced into the patient's body via a laparascope, avoiding the need to perform surgery under anaesthesia.

LCT's executive director, Roger Coats, if the procedure works as well in human diabetics as it has done in animal models of diabetes, the company will substitute porcine islet cells.

Islet-cell transplantation works very well, but patients must take immunosuppresants that leave them exposed to infection and cancers. The scarcity of human pancreatic islet-cell for transplants restricts the number of operations to a few hundred per year.

Coats said the US$150,000 to US$200,000 cost of the human islet-cell transplant procedure is also prohibitive, and the cost of immunosuppressant drugs can run to US$12,000 a month.

The use of porcine cells, and the simple laparascopic procedure, could make islet-cell therapy accessible to many more of the world's estimated 170 million type 1 diabetics.

Because researchers have not yet identified stem cells that give rise to islet cells, LCT will harvest pancreases from a herd of remarkable pigs that are virtually free of all major pig pathogens.

The pigs were bred from animals selected from a herd of wild pigs discovered on a remote island between New Zealand and Antarctica -- the herd is descended from a few animals marooned on the island by visiting sailors in the 19th century.

Coats says animal trials indicate that the encapsulated islet cells could deliver stable, save levels of insulin to human diabetics for at least three months before the alginate coating breaks down, exposing the cells to immune-system attack.

"We're hoping to achieve three months before the patient needs to be re-administered, but that compares with only 24 hours for injected insulin," Coats said.

The 'alienness' of the porcine cells will actually be an advantage because when the alginate capsule eventually dissolves, immune systems will kill them more rapidly than human cells, minimising any risk that any residual pathogens, including porcine retroviruses, could cause infections.

LCT is also developing cell-transplant therapies for haemophilia and neurodegenerative disorders using the same alginate-encapsulation technology.

IPO next month

LCT was formed in 1987 to develop and commercialise cell therapies for a range of human disease. The company is already listed on the Newcastle Stock Exchange, and will list on the Australian Stock Exchange on July 14.

Other life science firms queuing for ASX listing include stem cell firm CyGenics, wound repair specialist Avastra, infectious disease and cancer researcher BioPharmacia, ophthalmology company Regenera, and pharmaceutical distributor Genepharm.