Posted by Ellen on November 04, 2001 at 06:01:02:
New Zealand Diabetes Technology Receives International Recognition Human Clinical Trial a Success << back
Press Release by Diatranz Ltd at 9:40am, 4th November 2001
In a world first, the transplantation of New Zealand produced insulin-carrying cells from newborn piglets has freed one child from the regime of insulin injections to treat her diabetes.
Diatranz Ltd Chairman, Mr. Graeme Avery, said today the potential breakthrough in xenotransplantation — replacing human tissues with animal equivalents and doing so without the need of immuno- suppressants — was of enormous medical significance.
The trial involved twelve diabetics aged 10-15 years in Mexico and was carried out by Diatranz research collaborator Doctor Rafael Valdes who presented his results at an International Xenotransplantation Association Congress in Chicago recently.
Diatranz is an Auckland based company which has been researching islet cell transplant technology for 13 years, based on internationally recognised research by Professor Bob Elliott, Diatranz' Medical Director and former Professor of Child Health at the University of Auckland.
Professor Elliott and Dr Valdes, who works at the Children's Hospital of Mexico, said the trial of the transplanted cells indicated one of the children attained full recovery and no longer requires injected insulin. Three reduced their insulin requirement by more than 40 per cent and the rest reduced theirs to a lesser extent.
"In clinical terms this is a remarkable result and holds out great hope for islet transplantation as a way of overcoming the complications of blindness, kidney failure and vascular disease which invariably occur". Professor Elliott said today.
"The impact of diabetes is greater than cancer and is probably the single most underestimated cost in medical care in New Zealand, being second only to the cost of mental health. Research shows that the incidence of diabetes in New Zealand will double by 2025, and its impact is particularly noticeable in our Polynesian population where 40 per cent of adults over 40 years of age have diabetes.
"Given that the average lifespan of a diabetic is much reduced we believe that pig islet cell transplantation holds out the best chance to overcome the debilitating impacts of the disease when treated in the traditional way."
Mr. Avery said that Diatranz Virologist Dr Olga Garkavenko presented a paper at the Congress in Chicago. Dr Garkavenko's research gave evidence that the major concern with pig cell islet transplantations - that of cross-contamination of a virus found in pig cells, called Porcine Endogenous Retrovirus (PERV) - was no longer a significant issue.
Dr Garkavenko's research indicates that the pig cells produced by a specially quarantined and bred pig herd in South Auckland are free from many of the pig diseases found elsewhere in the world. These have been shown to not be capable of infecting human cell lines with PERV in laboratory trials under what Dr Garkavenko describes as "the most exhaustive conditions".
Dr Garkavenko said the conclusion of the Congress was that PERV and other viruses were no longer a constraining issue in relation to xenotransplantation. Her Team's research gave a confirmation that the pig cells produced are not capable of infecting human cell lines with PERV. The backup of very good science in pig breeding and the use of reliable assays for patient follow-up would address any issues of infection.
"New Zealand has important advantages in that it has not imported any pigs since 1987 it is geographically remote and has very high standards of animal husbandry," Dr Garkavenko added.
The Congress Panel in its' concluding remarks said that the field of porcine xenotransplantation should move towards clinical trials "as has been done in Mexico".
Chairman Graeme Avery said, "This statement was of great importance to Diatranz. Not only does it do credit to the work of the Diatranz Team, it supports the Company's research programme in this application and that involving the use of other cells for the treatment of similar diseases. It also justifies Diatranz' planned further human clinical trials to give confirmation to the diabetes treatment. The first of these is about to start in San Marino in November of this year and a later second trial to be conducted in Italy. Both these trials would be carried out in collaboration with the University of Perugia."
He also said that Diatranz, by having a proprietary platform based on the only GMP rated animal facility in New Zealand, a commercial and well-assayed donor source based on special husbandry, international collaboration, and a competitive first product, holds a unique international opportunity in the field of living cell technologies.
ENDS