KEY POINTS:
Health Minister David Cunliffe has today permitted a pig-cell transplant clinical trial to test a potential new treatment for people with type 1 diabetes.
The start of the trial at Middlemore Hospital in Auckland has been held up for nearly a year while Mr Cunliffe sought fresh advice
after his appointment as minister last year.
The Government was subjected to last-minute lobbying by the Sustainability Council in October last year, which urged a new round of public consultation and raised concerns about potential new diseases from the treatment.
The trial in effect revives one stopped in Auckland in 1996 over concerns about the risk of transferring pig viruses, although no evidence has been found of this happening and the techniques for encapsulating the cells has advanced since 1996.
In the new trial, encapsulated cells taken from the cells of neonatal piglets of a specially reared pig herd will be transplanted into eight people with type 1 diabetes. The cells will be put in the abdomen.
Type 1 diabetes is an auto-immune disease whose cause is unknown. It usually starts in childhood and is not related to obesity. It affects around 15,000 New Zealanders.
People with the disease cannot produce insulin and have to inject themselves regularly with synthetic insulin, to control the level of glucose in their blood. It is hoped the pig cells will produce insulin for them.
The pig cells are produced by the biotechnology company Living Cell Technologies, which is also involved with a trial of the laparoscopic cell transplants in Moscow, which has shown promising results.
Mr Cunliffe said that in giving his conditional approval to the Middlemore trial he had taken into account the huge potential of so-called xenotransplantation (animal-to-human) for treating type 1 diabetes.
"The new treatment promises to achieve a better health status for people dependent on insulin."
"I would like to stress from the outset that this Auckland trial ... will be done under a very rigorous set of conditions that will meet international best practice standards."
After cabinet discussed the trial in March, he sought further consultation and advice from the National Health Committee. It recommended the trial proceed subject to conditions which the Ministry of Health and Living Cell Technologies (LCT) had agreed to.
The conditions included that all patient information and tissue samples of those in the trial be held in an archive at Middlemore Hospital and that the trial be overseen by an independent Data Safety Management Board.
If LCT ceased trading in New Zealand, they must transfer all patient records and tissue samples to the ministry.
"I have also required that any adverse events involving the trial must be reported by LCT immediately to the relevant authorities."
"This trial is also conditional on a favourable peer review by a leading international expert to be nominated by the Ministry of Health."
"It remains clear to me that any such trial will always carry a very low residual risk, so the key issue has always been whether this risk is sufficiently small and can be successfully managed.
"I am confident that the stringent conditions I have imposed on this trial represent best practice and meet our international obligations to the World Health Organisation.
"This is critical new technology that could well make New Zealand a world leader in both the treatment of diabetes and in the use of xenotransplantation."
Living Cell reported preliminary results of the Russian trial in April. Four adult type 1 diabetics had received small-dose transplants of the encapsulated cells. No anti-rejection drugs were needed.
Two of the patients had shown a significantly reduced need for insulin injections. The third patient's insulin needs increased, but for personal reasons that led to his eating more, not because of the treatment. The fourth patient had received her first implant in February and her insulin requirement was reduced by 10 per cent by just four weeks later.
No evidence was found of pig virus transmission to humans _ the safety issue raised by the Sustainability Council.
