Living Cell Technologies (LCT) won a license from the New Zealand Government to manufacture a novel animal cell product for humans. The NZ regulator MedSafe has allowed the use of its xenotransplant products in human patients.
“GMP accreditation is a significant milestone and is a necessary requirement to begin LCT’s clinical trial program,” says LCT’s managing director, Paul L.J. Tan. “As far as we know, LCT possesses the only accredited GMP facility to make xeno porcine products and will be able to manufacture its products in accordance with the regulations of any regulatory jurisdiction throughout the world.”
The scope of the GMP accreditation includes the company’s proprietary micro-encapsulation process and also the manufacture and preparation of free islets from neo-natal pigs.
LCT will now manufacture cell therapy products, including DiabeCell®. DiabeCell is a porcine islet cell transplant therapy for the treatment of insulin-dependent diabetes. The neo-natal pig cells produce insulin and help regulate blood glucose levels appropriate to the amount of glucose detected in the blood stream of the diabetic recipient, explains Tan.
According to Tan, this significant milestone is the first and most fundamental part in a three-step process to obtain approval for a human clinical trial in New Zealand in 2007. LCT must now receive a “Recommend for Approval” from MedSafe to conduct the clinical trial and final ethics approval.