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Experimental pig-cell transplants for diabetics are a step closer to resumption after a 10-year-ban imposed over animal-to-human disease fears.
The New Zealand regulator MedSafe yesterday gave the Living Cell Technologies biotech company a licence to manufacture its animal cell products for humans.
The licence is the first in a three-step process towards obtaining approval for human clinical trials in New Zealand next year.
Auckland scientist Bob Elliott, medical director of Living Cell, had been forced to halt his ground-breaking trial injecting type-1 diabetes sufferers with insulin-producing cells from pig pancreases in 1996 because of fears humans could be infected with pig viruses.
Managing director Dr Paul Tan said the accreditation was a significant milestone towards beginning its clinical trial programme.
The company now needs final ethics approval and a further go-ahead from MedSafe before it can proceed with its DiabeCell treatment for insulin-dependent diabetes.
The treatment involves transplanting insulin-producing neonatal pig cells into humans.
After preliminary consultation with MedSafe, the company applied this year to conduct clinical trials on eight long-standing insulin-dependent diabetics.
Professor Elliott said the licence was a strong vote of confidence in the company's research and its potential to significantly reduce the global epidemic of diabetes.
