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Govt approves pig-human tissue transplant medical trial

Tuesday 21 Oct 2008 12:00a.m.

Govt approves pig-human tissue transplant medical trial

Health Minister David Cunliffe has approved a clinical trial involving the transplantation of pig cells into humans.

Biotech entrepreneur Living Cell Technologies Ltd (LCT) wants to transfer cells from the pancreas of pigs to produce insulin in type-1 diabetes sufferers in a process known as xenotransplantation. The trial would be conducted at Middlemore Hospital, in South Auckland.

Though the technology could produce significant benefits for individual patients, it is highly controversial given the potential for a pig virus to be transferred that could then became capable of spreading as an infection in people.

But Mr Cunliffe today gave the trial the green light.

He said xenotransplantation had huge potential for diabetes sufferers.

"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."

The trial would be done under rigorous conditions that met international best practice, he said.

Those conditions included that:

* all patient information and tissue samples involved in the trial would be housed in an archive at Middlemore Hospital;
* the trial would be overseen by an independent data safety management board;
* if LCT ceased trading in New Zealand it must transfer all patient records and tissue samples to the Health Ministry;
* any adverse events must be reported to authorities immediately;

His approval of the trial was also conditional on a favourable peer review by a leading international expert to be nominated by the ministry.

"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," Mr Cunliffe said.

"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."

Mr Cunliffe said his decision followed consideration of a report by the National Health Committee and further advice from medicines safety agency Medsafe regarding international regulatory developments.

Key ministers were deluged with emails from around the world over the weekend in an apparently coordinated effort by advocates of the technology, in advance of yesterday's cabinet meeting.

But the New Zealand Medical Association (NZMA) warned in 2005 that a deadly virus transmission through this pathway could potentially kill millions of people.

When the current application for a clinical trial in NZ was made, a Wellington think tank, the Sustainability Council, urged the minister to consult the public on the "community risk" in the event that transplanted pig tissues triggered an infectious disease in humans.

It also questioned how transplant recipients could be stopped from donating blood or organs to other humans.

But LCT's medical director, Professor Bob Elliott, who carried out the original research, and actually injected pig cells into people in 1996 and 1997, recently said further delays would have the same effect on the company as a rejection.

"We can't wait around any longer really, we've got to move."

LCT has claimed it can limit risks by using tissues from piglets in a breeding line said to have been isolated from other pigs for over 150 years on the Auckland Islands.

According to Dr Elliott, a group of Russians injected with NZ cells last year showed reductions in daily insulin requirements ranging from 23 percent to as much as 100 percent, and had good control of blood glucose levels in four out of five patients.
Listen to Chief Operating Officer of Living Cell Technologies, Paul Tan, explain the procedure on RadioLIVE.
Watch the full interview with Professor Bob Elliot
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