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Living Cell Technologies trial approved

Hon David Cunliffe
Minister of Health

21st October 2008 Media Statement

Living Cell Technologies trial approved

The Minister of Health David Cunliffe has today conditionally approved a clinical trial for eight diabetes sufferers by the company Living Cell Technologies Ltd.

The Minister said in approving the trial he was mindful of the huge potential xenotransplantation had for the treatment of Type 1 Diabetes sufferers. “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, involving the transplantation of pig cells into diabetes patients to stimulate insulin production will be done under a very rigorous set of conditions that will meet international best practice standards.”

“Since this matter was discussed by Cabinet in March, I have sought further consultation and advice from the National Health Committee.The Committee recommended that the trial should proceed subject to certain conditions that both the Ministry of Health and LCT have agreed to” said Mr Cunliffe.

“Amongst those conditions I have asked for is that all patient information and tissue samples involved in the trial will be housed in an archive at Middlemore Hospital and the operation of the trial will be overseen by an independent Data Safety Management Board .”

“If LCT ceases trading in New Zealand they must transfer all patient records and tissue samples to the Ministry of Health,” said Mr Cunliffe

“I have also required that any adverse events involving the trial must be reported by LCT immediately to the relevant authorities. “

“This approval is also conditional on a favourable peer review by a leading international expert to be nominated by the Ministry of Health,”said Mr Cunliffe.

“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.”

Today’s announcement followed consideration of the National Health Committee’s report and the further advice provided by Medsafe regarding international regulatory developments.


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