KEY POINTS:
Eleven-year-old Sophie Foster likes the idea of having pig-cell transplants to treat her diabetes so she can occasionally have a lollipop as a treat.
Health Minister David Cunliffe yesterday approved a clinical trial at Middlemore Hospital in Auckland of the revolutionary technology in eight people with type 1
diabetes.
The company behind the treatment, Living Cell Technologies, expects the trial to start by February.
Sophie's parents, Karen and Rob Foster, and the support and lobby group Diabetes Youth welcomed the approval for the trial which, if successful, could lead to the treatment being licensed within three years.
Sophie, who was diagnosed with type 1 diabetes when she was 3, said she would consider having the treatment if it became available, because of the prospect of having better control of her blood-glucose levels, although she is unhappy about piglets having to be killed for it.
"Diabetes is quite a pain for me, because at my age a lot of people have sugary drinks and unhealthy food and I'm stuck with fruit and vegetables. I would like to eat other things, probably stuff like lollipops."
She has an insulin pump, which gives regular doses of insulin through a "port" into her abdomen. That gives better blood-glucose control than insulin injections, but the hope is that the transplants will stabilise blood-glucose levels even more and reduce or end the need for synthetic insulin.
This would simplify diabetics' lives and reduce the risk of complications such as blindness and kidney failure.
The pancreatic cells, from newly-born piglets, are coated in a gel made from seaweed to protect them from the human immune system.
This avoids the need for anti-rejection drugs, but allows the cells to secrete insulin in response to the body's needs.
The cell clusters are transplanted into the patient's abdomen.
Type 1 diabetes affects about 15,000 people in New Zealand. An auto- immune disease, it usually starts in childhood and its cause is not known. It destroys cells in the pancreas that produce insulin, a hormone needed so cells can use glucose.
The "xenotransplantation" - animal to human - trial application has been on the desk of Mr Cunliffe and his predecessor, Pete Hodgson, for more than a year.
Mr Cunliffe commissioned the National Health Committee to undertake further consultation.
He said the conditions he had imposed on the trial complied with the best practices internationally. They included that all patient information and tissue samples be held in an archive at the hospital and that the trial be overseen by an independent data safety management board.
"This is critical new technology that could well make New Zealand a world leader in the treatment of diabetes and in the use of xenotransplantation."
Living Cell medical director Professor Bob Elliott said recruitment of eight adults for the trial, from the many type 1 diabetics who had expressed interest, could start.
He said the average reduction in insulin doses was 25 per cent in the six-patient Russian trial of the cell transplants which began more than a year ago, and control of blood-glucose levels was improved.
The Middlemore trial would progressively increase the number of pig cells transplanted to help find the optimum dose.
If all continued to go well and the treatment was licensed, it would initially cost $100,000 a patient, but that was a small price compared to the lifetime costs of treating diabetes and its complications.
The National Health Committee said the risk of pig viruses entering the human population through the transplants could not be completely ruled out, but as there had been no instances of this happening, "the risk of infection to humans is considered low".
