An Auckland professor has won official approval to resume clinical trials for implanting insulin-producing pig cells into diabetics.
Health regulators blocked Professor Bob Elliott's initial controversial research over fears that the animal transplants could introduce pig viruses into humans.
Yesterday, the company for which Professor Elliott is medical
director said it had all the necessary approvals for new New Zealand trials.
Living Cell Technologies (LCT) chief executive Paul Tan said the company had obtained all the regulatory and ethics approvals required by Health Minister Pete Hodgson.
LCT - which is already carrying out similar trials in Russia - said it was the only company to obtain clinical trial approval for a pig-cell transplant without suppressing a patient's immune system.
Auckland's regional medical ethics committee has approved the company's clinical trial protocols.
LCT plans to resume implanting pig cells in New Zealanders by the end of the year.
The company has said it hopes to commercialise its DiabeCellB pig-cell transplants by 2012, targeting a global market of 24 million type-1 diabetes patients.
About 11,000 New Zealanders have type-1 diabetes, which can start in childhood and leave patients unable to produce much insulin, which the body uses to process glucose.
They need regular injections of synthetic insulin, but if millions of pig cells inserted into their abdomens can manufacture extra "natural" insulin, their dependence on injections would be reduced.
The company said yesterday it expected Mr Hodgson to accept the regulatory approvals in the next few weeks, so that it could start inserting pig cells into eight type-1 diabetics at Auckland's Middlemore Hospital.
In June it implanted cells from the pancreases of specially bred New Zealand pigs into the abdomens of six Russians - all adults who had had type-1 diabetes for at least 10 years.
That trial is being held at the Sklifasovsky Institute in Moscow and is being managed by GenyResearch Group of Boston.
This year, LCT received regulatory approvals from medicines regulator Medsafe and the Gene Technology Advisory Committee, and in May it became the first company to have an internationally accredited laboratory for testing to ensure the absence of infectious viruses and micro-organisms in pig tissue and a system for monitoring recipients of pig-cell implants.
- NZPA
