KEY POINTS:
Pig cells have been successfully transplanted into the first patient in the new human trials of a revolutionary diabetes therapy pioneered in South Auckland.
The 26-year-old man, who has had type 1 diabetes for at least 10 years, had the transplant in Russia last week.
He is said
to be doing well after the clusters of insulin-producing cells from the pancreases of neo-natal piglets, encapsulated in a special gel to protect them from the human immune system, were inserted into his abdomen.
Paris Brooke, general manager of Living Cell Technologies in Melbourne, which makes the therapy in New Zealand, said yesterday it was not yet known if the patient's need for insulin injections had been affected.
"That will take a little while. It takes a while for the cells to bed down in the system.
"We won't expect to see those types of effects for quite a few weeks and then that will be monitored over the period of the trial as well. But we certainly expect to see a reduction in insulin requirements for sure."
Living Cell, which is listed on the Australian Stock Exchange, hopes to commercialise the type 1 diabetes therapy for general use by 2012.
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's medical director, Professor Bob Elliott, who developed the therapy, said the plans for a New Zealand trial at Middlemore Hospital in Otahuhu were proceeding well and should start in November or December.
The Health Ministry's Medsafe unit had approved the local trial, but it was still before a regional ministry ethics committee, and after that, Health Minister Pete Hodgson would have to sign the plan off.
The Russian trial, at the Sklifasovsky Institute in Moscow, which has extensive experience in organ transplantation and xenotransplantation (animal-to-human transplants), is being overseen by a Boston medical research company to ensure it keeps to international regulatory standards.
The capsules containing the pig cells are the size of a pin head and each of the six adults in the Russian trial will receive billions of the cells.
The encapsulation avoids the need for anti-rejection drugs, but still allows the pig cells to respond to the patient's insulin needs, releasing the substance as required. The patients will receive two low doses of the cells every six months for a year, followed by another year of study of the therapeutic effect.
In this trial, patients are given the lowest clinically effective dose to demonstrate safety.
The dosing is repeated for extra clinical benefit.
The trials are effectively a continuation of an Auckland trial halted in 1996, although the therapy has been improved.
The 1996 trial was stopped after six patients were treated because new research suggested pig-cell xenotransplants could allow pig retroviruses to jump to the human population.
But Living Cell, which has tested the therapy on animals, says there is no evidence of humans or other animals being infected by the viruses.