Insulin xenotransplantation trial gets go ahead

Australian biotech Living Cell Technologies (LCT) has been given the green light to start a xenotransplantation trial in diabetic patients in Russia.

The Phase I/IIa trial involves patients with type 1 diabetes receiving injections of porcine pancreatic cells encased in capsules. It will include six participants with type 1 diabetes, who will not have to receive immunosuppressants, and will take place at a specialist organ and xenotransplantation hospital in Moscow.

Xenotransplantation is not allowed in Australia following the institution of a five-year moratorium by the National Health and Medical Research Council in 2004.

LCT's product, DiabeCell, is made from neonatal pig islet cells encased in an alginate capsule. Nutrients can pass through the capsule to the cells and insulin from the cells can pass into the body. The company said antibodies cannot reach the cells inside the capsule, preventing rejection by the patient's immune system.

The encapsulated cells are injected into the body and produce insulin in response to the levels of glucose in the blood.

The company said DiabeCell offered considerable advantages over other treatments, including no need for immunosuppressive drugs and the ready availability of the insulin-producing cells from LCT's pig herds.

LCT's scientific advisor Dr John Court, an expert on adolescent diabetes, said it was the only human clinical trial of its kind approved anywhere in the world.

"It recognises LCT's thorough pre-clinical testing of the product in animal models, which showed no adverse safety effects and a significant reduction in insulin requirements," Court said.

LCT has completed trials with diabetic mice and primates to establish safety and the ability to treat type 1 diabetes. The company said the results showed that DiabeCell was well-tolerated and led to a reduction in the insulin requirements on average for primates with diabetes.