Ethical approval for pig cell brain trial
Friday 16 Nov 2012 2:50 p.m.
Plans to trial transplanting pig cells into the brains of New Zealanders with Parkinson's disease have cleared a major hurdle with the Ministry of Health granting ethical approval.
The ministry's health and disability ethics committee granted approval ahead of trials due to begin in the first quarter of next year, the company behind the trials, Living Cell Technologies (LCT), said on Friday.
Medsafe gave LCT regulatory authorisation last month.
It took about two years for LCT to get ethical approval following regulatory authorisation in 2007 for its pig cell diabetes treatment trial.
"We are extremely pleased to have received ethical approval in such an efficient timeframe," said LCT managing director Andrea Grant.
LCT will now need to get a good manufacturing practices licence for the trial to proceed.
Pre-clinical trials suggest the Parkinson's treatment, known as NTCELL, can protect brain tissue which would otherwise die, potentially delaying or preventing the effects of the neurodegenerative disease.
Only those who have been diagnosed with Parkinson's for at least four years will be part of the study, which will last for up to 60 weeks.
The trial will involve patients getting either the pig cells or the current gold standard of treatment - deep brain stimulation.