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Pig-human tissue transplantation given green light
NZPA Tuesday October 21 2008 - 09:27am
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.
