The New Zealand Ministry of Health has authorised clinical trials for the Living Cell Technologies (LCT) drug for people with insulin-dependent diabetes Diabecell.
The authorisation was confirmed following agreements on certain conditions for the trials announced on 19 June 2009.
One such condition of the new authorisation limits participation in the trial to only patients with poorly controlled (brittle) diabetes.
The remaining conditions are procedural rather than substantive in nature and LCT and the Middlemore Hospital clinical team has requested the Regional Ethics Committee to accept the changes required by the Minister.
LCT CEO Dr Paul Tan said that the company is pleased that the conditions have been finalised. LCT looks forward to commencing the trial within the next two months with the acceptance of the changes by the Ethics Committee.