New Zealand to trial pig cells as treatment for type 1 diabetes

Oct 21 2008

Authorities in New Zealand have given conditional approval for a human trial to go ahead using pig cells to treat type 1 diabetes.

As part of a clinical trial New Zealand-based firm, Living Cell Technologies (LCT) will transplant the pig cells into eight people with type 1 diabetes.

The approval from the Ministry of Health follows an application from LCT which has been planning the research for two years.

The trial will use a form of xenotransplantation which involves injecting pig cells that produce insulin into people with type 1 diabetes to reduce their need for regular insulin doses.

The Health Minister says the trial will be held shortly at Middlemore Hospital in Auckland, subject to one final review and follows considerable research to ensure the chance of retroviruses in the cells being transferred to people are minimal, if any.

LCT chief operating officer, Paul Tan, says they are confident of gaining full approval as concerns about pig retroviruses have diminished.

The Minister of Health David Cunliffe says in approving the trial he was mindful of the huge potential xenotransplantation had for the treatment of type 1 diabetes sufferers and Mr Tan says there is no shortage of people with type 1 diabetes who are eager to take part.

David Cunliffe says says the new treatment promises to achieve a better health status for people dependent on insulin and the trial will be done under a very rigorous set of conditions that will meet international best practice standards.

Mr Cunliffe says he has had consultations and advice from the National Health Committee who recommended that the trial should proceed subject to certain conditions that both the Ministry of Health and LCT have agreed to.

The conditions include all patient information and tissue samples in the trial being archived at Middlemore Hospital and an independent Data Safety Management Board overseeing the trial.

Any adverse events involving the trial will be reported by LCT immediately to the relevant authorities and Mr Cunliffe says the approval is conditional on a favourable peer review by a leading international expert to be nominated by the Ministry of Health.

Mr Cunliffe says he believes any such trial will always carry a very low residual risk and the key issue has always been whether this risk is sufficiently small and can be successfully managed.

He says he is confident that the stringent conditions imposed by the Ministry on the trial represent best practice and meet international obligations to the World Health Organisation.