The trial, being conducted in New Zealand by Living Cell Technologies, involves eight adult patients with established type 1 diabetes and hypoglycemia unawareness – a constant inability to sense when blood glucose levels are dropping dangerously low.

Each patient has been surgically implanted with insulin-producing cells taken from specially bred pigs in a technique known as xenotransplantation – the transplantation of animal organs or tissues into humans to cure or treat health conditions.

Xenotransplantation is a growing field of interest for researchers as the use of animal tissues will circumvent the current shortage of human organ donors. It is also controversial in that some scientists believe undetected animal diseases could be transferred to humans.

The pig islet cells used in this trial were taken from a special herd of pigs that live on a remote island off New Zealand. The isolation of the colony has meant they have been theoretically untouched by the diseases that affect mainland pig herds.

The islet cells were also encapsulated in a special new substance made from seaweed – thus protecting the cells from immune attack whilst allowing the appropriate amount of insulin to be released effectively.

Living Cell Technologies scientists believe that using this technique will result in the transplanted cells will be able to safely effectively produce insulin and help control blood glucose levels without needing the harmful life-long regime of immune-suppression drugs that all organ transplant patients currently require.

Early results from the trial have shown that the implants do have an impact with one of the recipients reporting significantly reduced hypoglycemia unawareness.

Whilst xenotransplantation is banned in a number of countries, the New Zealand government has provided special dispensation for this trial to go ahead. The Australian National Health and Research Council has recently overturned a moratorium on animal-to-human transplants but guidelines are yet to be constructed to ensure any local trials are ethically and scientifically sound.

JDRF provides industry partnership funding to a number of large and small companies around the world to advance promising research into a cure for type 1 diabetes and type 1 diabetes complications.

Find out more about these research programs.

In Australia, and many other countries around the world, stem cell therapy is only approved to treat blood disorders such as leukemia. Whilst research is moving rapidly and showing great promise, the use of any type of stem cell as a therapy for diseases like type 1 diabetes is still firmly classed as experimental. This doesn’t mean these therapies won’t work, just that scientists and clinicians have deemed there isn’t enough data available to demonstrate patient safety as well as a long term benefit.

Not all countries have such strict protocols for demonstrating the safety and worth of a medical treatment, and a number of stem cell “clinics” have taken advantage of this lack of regulation. Often advertising via the media or internet, the treatments offered at these privately run centres are often extremely expensive and have little to no scientific rationale. Worryingly, the International Society for Stem Cell Research has also shown that a large number of these programs have little regard for patient health and safety, and in many cases, are highly unlikely to provide any benefit whatsoever.

There are places where you can find out more. If you are considering any kind of overseas medical therapy, your first port of call should always be your medical specialist or health care provider. They will be able to give you a run down of what is, and what may soon be, available to you. The government-funded Australian Stem Cell Centre has also published a handbook for people considering stem cell therapy. As well as providing lots of information about how stem cells work, it aims to provide the information required to make an informed decision.

You can go to the Australian Stem Cell Centre website for more information, www.stemcellcentre.edu.au, and to obtain a copy of the patient handbook.

Questions to ask when considering stem cell treatment

Is the treatment offered within a mainstream medical environment?

In Australia, proven stem cell treatments are available through the public health system. All experimental treatments and clinical trials must be undertaken at an institution that has been accredited by a relevant Federal Government agency (usually the NHMRC). Not all countries place such a focus on patient safety so understand what regulations do exist and make an informed decision of the potential risks versus the advertised benefits.

Does the provider charge for the treatment?

In Australia, any accepted mainstream stem cell treatment will receive some level of reimbursement from either Medicare or a private health fund. Experimental treatment received as part of a clinical trial should not incur any charges at all, and this is the case in many other countries as well.

What evidence do they use when promoting the therapy?

The best way to assess if a therapy is effective is to check if it has been written up in the scientific literature and been assessed by government sanctioned clinical trials. Don’t be shy to ask for copies of their research publications, results of previous clinical trials and copies of relevant government approvals – they will gladly give them to you if the therapy is proven and accredited.

Patient testimonials and media coverage are NOT evidence that a therapy is safe and effective. Remember it is possible to make all kinds of unproven claims, particularly on the internet, so contact a local health agency or disease advocacy group to establish their credentials.

Where do the stem cells come from?

Whilst we talk about stem cells as a single entity, there are in fact a number of different sources of cells that can act in very different ways. If the proposed treatment involves stem cells from an external source (for example donor tissue, cord blood or embryonic cells) it is highly likely that your body will reject the foreign cells unless immune-suppression therapy is also given. If the stem cells have been taken from animal tissue there is a risk of infection from animal viruses. Embryonic stem cells, if introduced in an undifferentiated state, may become cancerous cells.

What does the therapy involve?

Whilst the type of stem cell used is important, so is the process by which it is administered. Whilst the basic hygiene of the medical centre is obviously important, the standards of any associated laboratory procedures are also critical to prevent contamination and infection. Many therapies involve quite serious medical interventions such as lumbar punctures. These procedures themselves can be risky and really should only be conducted when absolutely necessary. Finally, make sure you identify if follow-up medical care is provided.

The ban was originally established by the NHMRC in 2004 to allow for further research into the possible side effects of the technique, particularly concerning the potential transmission of disease from animals to humans.

The NHMRC has now concluded that xenotransplantation research can proceed and that the associated risks with xenotransplantation are minimal and acceptable given the potential benefits.

Whilst the ban has been officially lifted, there are still a number of strict guidelines that need to be followed before xenotransplantation research can take place. These include the development and implementation of strict national frameworks, administered by the Therapeutic Goods Association, to ensure all clinical trials are sufficiently monitored and regulated. Animal welfare and ethics organisations will also be responsible for maintaining a high level of animal care.

Xenotransplantation research holds considerable promise for people with type 1 diabetes, particularly in the area of islet transplantation. JDRF funds a number of research projects in Australia and overseas looking into the possibility of using transplanted pig islet cells to replace the human cells lost during the disease process.

So far, xenotransplantation has had positive results in studies overseas. Researchers at two JDRF islet transplant centers in the United States were able to safely and effectively reverse diabetes in a number of animal models including monkeys by transplanting islet cells from pigs.

Dr Dorota Pawlak

“JDRF fully supports the NHMRC’s decision to allow clinical xenotransplantation research in Australia,” says JDRF Research Manager, Dr Dorota Pawlak.

“When used under strict ethical and scientific guidelines, xenotransplantation techniques have the potential to save the lives of thousands of people every year.”

“This is especially true for people on organ donor waiting lists and those living type 1 diabetes. These people urgently need to replace the insulin-producing cells destroyed by the disease and there is a very real possibility that this can be done using xenotransplantation.”

If you would like more information about xenotransplantation, go to the NHMRC website or call JDRF on 1300 363 126.

The book and accompanying series of podcasts was launched today by the Parliamentary Secretary for Health, the Hon Mark Butler MP, with the aim of encouraging the next generation of health and medical researchers.

“10 of the Best is testament to the excellence and innovation of Australian health and medical research,” Mr Butler said. “These inspiring projects show the challenges, rewards and potential for effecting real change that comes from working in this frontier area of science.”

“We need more researchers like these – individuals with the ingenuity, drive and dedication to unravel the mysteries behind disease and relieve human suffering.’

10 of the Best describes the research led by Professor Len Harrison at the Walter and Eliza Hall Institute in Melbourne, which is part of a major clinical trial of a promising potential vaccine for type 1 diabetes. The trial is co-funded by the NHMRC and JDRF.

Professor Harrison said “We can now identify individuals many months or years before they develop symptoms and we can prevent the disease in an animal model,” Len says.

“I am passionate that by extending our discoveries into the clinic we will eradicate this disease in humans.”

JDRF’s CEO Mike Wilson congratulated Professor Harrison on the prestigious inclusion of the type 1 diabetes vaccine trial amongst the country’s best research projects. “This is due recognition of the world-leading standard of Australian type 1 diabetes research as well as the significance of Professor Harrison’s work.”

To read the full report, visit the NHMRC website.