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Scientists consider using animals in transpla -

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PETER CAVE: A debate has begun over whether Australia should change its laws to allow scientists to
transplant animal cells and organs into humans.

The risks of xenotransplantation, as it's known, include infection with unknown agents from the
animals.

But a scientist says there's also much to gain. He says that overseas trials show that diabetes
patients have benefitted from the injection of pig cells and the Australian regulator is neglecting
its duty of care by not allowing xenotransplantation.

As Simon Lauder reports, Australia's moratorium on xenotransplantation is up for review later this
year.

SIMON LAUDER: Type 1 diabetes occurs when the immune system destroys the body's own insulin
producing cells. Without daily injections it can be life threatening.

But the medical director of Living Cell Technologies Professor Bob Elliot is working on another
solution - replacing human cells with animal cells.

BOB ELLIOT: Using those microencapsulated pig insulin producing cells we have in a pilot study
where we've injected these into the peritoneal cavity, the belly cavity of type 1 diabetics, adult
type 1 diabetics, that two of those had shown sustained insulin independence following that
procedure.

One of those, our best patient so far, is still independent, insulin independent six months after
her injection of these cells.

SIMON LAUDER: The technique which is broadly described as xenotransplantation is the topic of an
online forum organised by the Australian Science Media Centre this morning.

The director of the Immunology Research Centre at Melbourne's St Vincent's Hospital, Professor
Anthony D'Apice explains.

ANTHONY D'APICE: It's the transplantation of living, that's the key word, living cells, tissues and
organs from one species to another. So things like pickled (phonetic) heart valves or tendons do
not qualify.

SIMON LAUDER: Putting animal cells and organs into humans is risky. Professor D'Apice again.

ANTHONY D'APICE: The risk of failure such as graft loss, the risk of infection, which is not just a
problem for the patient but possibly for their contacts and the community, and that may be
infection with known or unknown organisms including porcine endogenous retrovirus.

And also minimising risk from immunosuppression. The distance between a pig and a human is
substantial. The amount of immunosuppresion that potentially is required could be substantial.

SIMON LAUDER: Professor Bob Elliot and his team have just received permission from the New Zealand
Government to conduct clinical trials of his technology. He's already conducted trials in Russia.

Professor Elliot says he's reduced the risk of infection from the pig cells as much as he possibly
can by selecting pigs which carry no agent which is known to be infectious to humans.

BOB ELLIOT: We monitor these pigs regularly. They are housed in an environment which does not
permit the entry of external organisms except perhaps through the attendants and they are
thoroughly vetted and must shower in and garb up in sterile clothing and so on. They have sterile
water, sterile bedding, sterile food.

SIMON LAUDER: After a lengthy consultation process the Australian Government put a five year
moratorium on any clinical trials of xenotransplantation.

The National Health and Medical Research Council deemed in 2004 that the risk of animal to human
viral transmission was not well understood.

Professor Bob Elliot says the Australian regulator is blocking the public health benefits of
xenotransplantation. He's keen for the moratorium to end.

BOB ELLIOT: This might be suggested is now unreasonable and I believe you can go a little further
than that, saying that a moratorium which doesn't allow a clinical trial under suitable
precautionary circumstances is failing in the duty of care which isn't just that of physicians or
researchers towards a community but also includes regulators.

SIMON LAUDER: The University of Auckland's Associate Professor Martin Wilkinson was the chairman of
the New Zealand Bioethics Council. He says the Australian Government will have to consider the
possibility that humans involved in xenotransplantation procedures may not be the only ones exposed
to the risk of contagious disease.

MARTIN WILKINSON: Because xenotransplantation raises at least a possibility of a disease spreading
from the recipient to other people this makes it as a clinical treatment or as a research trial
different from others because the people that are affected are no longer just those people who are
consenting.

Having said that we have to be careful what conclusions we draw from it. First of all the risk of
disease from xenotransplantation is highly variable according to the sort of xenotransplantation it
is. So transplanting a baboon's heart is much riskier than transplanting porcine eyelet cells.

SIMON LAUDER: The National Health and Medical Research Council is due to review Australia's
position on xenotransplantation by December.

PETER CAVE: Simon Lauder reporting.