Everything you need to know about… xenotransplantation
What is xenotransplantation?
For type 1 diabetes, xenotransplantation involves taking insulin-producing islets from animals —in this case, pigs—and transplanting them into people. Pigs are considered the best species for xenotransplantation because pig organs are similar in size and physiology to human organs and pig insulin has been shown to work effectively in humans.
Earlier this year, the Australian government’s National Health and Medical Research Council lifted a moratorium on the clinical use of xenotransplantation. The ruling came after five years of research into the possible side effects of the technique, particularly the potential transmission of disease from animals to humans. It concluded that xenotransplantation research can proceed, given that researchers adhere to strict guidelines, and that the associated risks with xenotransplantation are minimal and acceptable given the potential benefits.
How is xenotransplantation different from human islet transplantation?
Researchers and clinicians have used human islet cell transplantation to treat type 1 diabetes for over a decade. Some countries now fund the procedure as a standard treatment for people living with serious hypoglycemic unawareness.
The two main challenges for effective islet cell replacement in people with type 1 diabetes are the supply of cells available for transplant, and the need to suppress the body’s immune system.
The use of islet encapsulation technology, in combination with xenotransplantation techniques or stem cell technology, could help overcome the obstacles to effective human islet cell replacement.
Who is Living Cell Technologies?
Living Cell Technologies (LCT) is an Australian publicly-listed company working to develop and market the use of pig cells as treatment for human disease.
What research are they doing into type 1 diabetes
LCT has recently started human clinical trials in New Zealand to test one of their products as a treatment for type 1 diabetes. Called Diabecell®, this product comprises encapsulated, insulin-producing islet cells taken from specially bred pigs.
The pigs used for transplantation in the LCT study are grown and harvested in optimal conditions, and their health status is closely monitored, reducing the safety concerns. Viruses from pig cells have not been shown to be capable of passing to humans during this type of xenotransplantation.
How far has the research of LCT progressed?
Research into this product is still in relatively early stages. One initial clinical trial has been completed in Russia and a new trial is currently underway in New Zealand. These trials, consisting of 8 people each, have been primarily designed to provide initial data on the safety of the treatment on adults living with type 1 diabetes and hypoglycemic unawareness.
The trials will also provide preliminary data on clinical outcomes to inform the larger scale trials required to fully test treatment effectiveness. Results and analysis from the initial clinical trial have yet to be published in the scientific literature.
How is JDRF involved?
JDRF has provided funding support for the second stage of the NZ trial to test the safety and effectiveness of Diabecell® when given in higher doses. Four patients will receive this higher dosage and results will be compared to those who received the lower doses. This trial is expected to be completed in 2011.
When will the treatment be available for people with type 1 diabetes?
The technique is currently only approved for clinical testing purposes in Russia and New Zealand. As with all new medial techniques, extensive research must be completed to ensure maximum safety for treatment recipients and also to establish standard protocols for use before being made widely available.
It is too early to tell if and when this product will be commercially available as a treatment for type 1 diabetes.
Is JDRF funding any other projects involving xenotransplantation or islet encapsulation?
Yes. Islet encapsulation and xenotransplantation are important areas of research for JDRF as part of the beta cell therapies program. Over the past five years, JDRF has invested US$13 million into xenotransplantation research, and approximately US$8 million into encapsulation research worldwide.
In Australia, JDRF currently supports three research programs into the use of pig islets as therapy for type 1 diabetes.
The JDRF funding for Living Cell Technologies was provided through the international Industry Discovery and Development Partnership Program, designed to accelerate the discovery, development, and commercialization of disease-modifying therapeutics.
Hmmm – "In Australia, JDRF currently supports three research programs into the use of pig islets as therapy for type 1 diabetes."
Yet – "Earlier this year, the Australian government’s National Health and Medical Research Council lifted a moratorium on the clinical use of xenotransplantation. "
So how could JDRF already be supporting another two programs in xenotransplantation (apart from the new one with LCT – when such studies were banned????
Who else is conducting xenotransplantation studies in Australia? (Remember LCT has only done studies to date offshore – precisely because of those bans).
JDRF was able to support xenotransplantation research in the lab, including those three research programs. But now, as the National Health and Medical Research Council has lifted a moratorium, can move that research into human clinical trials.
I am so glad to see that the JDRF is supporting this research. Using pig islet cells will provide many more diabetics who need this treatment the opportunity to have an islet cell transplant. There are simply not enough human islet cells available to go around. Not only will this allow more people to escape from diabetes, but it will increase our knowledge of islet cell transplantation in general.
Is it possible to be a part of the clinical testing in New Zealand?
I AM SICK OF HEARING OF WONDERFUL ADVANCEMENTS TOWARDS CURE FOR TYPE 1 DIABETES – NEARLY 30 YEARS I HAVE HAD THIS DISEASE, NOTHING HAS REALLY CHANGED, I STILL NEED SEVERAL NEEDLES DAILY AND NUMEROUS BLOOD TESTS DAILY, JUST THE SAME WHEN DIAGNOSED IN 1983. THE ONLY THING IS I NOW HAVE TO DO THE SAME FOR MY DAUGHTER WHO WAS DIAGNOSED AT AGE 4. WHY CAN'T THEY DO SOMETHING TO HELP THE CHILDREN WHO SUFFER THIS HORRIBLE DISEASE, AS I WATCH MY DAUGHTER WHO IS NOW 10 SUFFERING LIKE ALL OTHER CHILDREN. GIVE THEM BACK THERE CHILDHOOD AND HURRY WITH A CURE.
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