NHMRC sets five-year moratorium on organ xenotransplantation

The National Health and Medical Research Council has recommended a five-year moratorium on any clinical research into animal-to-human whole organ transplants in Australia.

But a decision on cellular transplantation - such as that being conducted by Adelaide company Living Cell Technologies (ASX:LCT), will not take place until at least December, according the NHMRC chief executive officer, Professor Alan Pettigrew.

Although the moratorium will not be enacted in legislation, Pettigrew said that the NHMRC provides guidelines for institutional ethics committees, which are sufficient for those committees to forbid whole organ transplant research.

In making its decision, the Council relied on the recommendation of its Xenotransplantation Working Party.

"[This decision is the result of] several years of consultation with the community and experts and review of the literature," said Pettigrew. The NHMRC took into account community concerns raised during two rounds of national consultation, including fear of new infectious diseases transferring from animals to humans and ethical and social concerns about the use and welfare of animals.

Rulings on the use of animal cellular therapies and animal external therapies, both of which have a lower potential risk of infection and higher expected benefit to humans than animal organ transplants, are yet to be made.

Animal cellular therapies involve the transplantation into humans of animal cells such as pancreatic islet cells to treat people with diabetes, or brain cells to people with Parkinson's disease.

Animal external therapies are defined as contact between human and animal cells outside the body, such as when human cells or tissue is cultured with animal cells in the laboratory in for a procedure such as a skin graft.

"The council has asked for more information before we finalise our advice on those issues," said Pettigrew. "[We require] an update on the scientific aspects on potential animal cell therapies. We will also seek advice from regulators in that area - including the TGA, the Gene Technology Regulator and state jurisdictions.

"The Americans have guidelines on this and up to this point in time the NHMRC have adopted the FDA guidelines as our interim guidelines. "We are taking the matter on to finalise it as a council matter and our next Council meeting is in December."

Roger Coates of Living Cell Technologies - which is developing a diabetes treatment, based on the transplantation of porcine pancreatic islet cells -- confirmed that this week's NHMRC decision didn't affect the company. "We don't do whole-organ transplantation.," he said. The US FDA put guidelines for xenotransplantation were put in place in April 2003