KEY POINTS:
A breakthrough New Zealand pig-cell transplant therapy that could transform the treatment of type-1 diabetes has been given the go-ahead for trials in humans.
But it is Russia, not New Zealand, that has approved the first clinical trial of the treatment, developed in South Auckland more than a
decade ago by pioneering Professor Bob Elliott.
The Ministry of Health hopes to make a decision within weeks on a similar application by Living Cell Technologies to run a second human trial of its treatment, from Middlemore Hospital in South Auckland.
The animal-to-human "xenotransplants" involve taking clusters of insulin-producing cells from the pancreases of newborn piglets, coating them in a seaweed-based gel and inserting the pinhead-sized capsules into the abdomen of a patient with type-1 diabetes.
Each of the six adult patients in the Russian trial will receive billions of the pig cells.
Unlike similar treatments, no drugs are given to suppress the immune system. The capsules admit substances like glucose, which stimulate the production of insulin, but they protect the pig cells from immune-system attack.
The piglets, from specialised herds in Auckland and Invercargill, are descended from those left on the Auckland Islands 200 years ago. They are killed for their pancreases.
The year-long Russian trial, which might start as soon as April, could be seen as the continuation of one abandoned in Auckland in 1996, although the technique has been improved and tested on animals in the meantime.
The trial will be run at a Moscow hospital by a specialist who already transplants rabbit cells to treat type-1 diabetics.
In animals with diabetes, Living Cell's pig-cell transplants produced no adverse effects, a significant reduction in insulin requirements and freedom from insulin dependence in some cases. It is hoped the results will be similar in humans.
One of the participants in the 1996 trial, Aucklander Michael Helyer, was tested last year and said he was still deriving some benefit from the pig cells.
Type-1 diabetes affects about 11,000 New Zealanders. It usually starts in childhood and leaves people unable to produce insulin, a substance the body uses to process glucose. They need regular injections of synthetic insulin.
Living Cell chief executive Paul Tan said if its "DiabeCell" was proven to be safe and effective through a series of clinical trials, it could be on the market internationally in five years.
"Russia may be able to commercialise that more quickly because other forms of xenotransplantation are permitted there."
Diabetes Youth NZ president Adrian Coombe yesterday welcomed the trial. He said his 16-year-old step-daughter Nicole, who has the disease, follows Living Cell's developments closely and would certainly consider having the treatment.
Dr Tan is disappointed New Zealand was not first with the new trial.
Wary of potential criticism that a softer regulatory jurisdiction had been chosen, he emphasised that the Russian trial would adhere to international and United States Food and Drug Administration standards.
After six patients were treated in the 1996 trial it was halted when new research suggested pig-cell transplants could infect humans with pig retroviruses. But Living Cell says there is no evidence of humans or other animals being infected.