NHMRC takes harder line on xenotransplantation

Following its ban on xenotransplantation earlier this year, The National Health and Medical Research Council (NHMRC) has made a surprise announcement of a five-year moratorium on clinical trials in Australia using animal cellular therapies or animal external therapies.

In October, the NHMRC banned clinical research into animal-to-human whole organ transplants in Australia.

The new ban covers transplantation of animal cells into humans and processes where there is contact between human and animal cells outside the body, such as in tissue cultures for skin grafts. Both technologies reportedly have a lower potential risk of infection and higher expected benefit to humans than animal organ transplants, and were expected to be less strictly regulated.

Although the moratorium will not be enacted in legislation, the NHMRC provides guidelines for institutional ethics committees, which are sufficient for those committees to forbid the relevant research.

Living Cell Technologies (ASX:LCT), one of most successful biotech floats of 2004, has reached pre-clinical stages with treatments for diabetes and Huntington's disease using transplanted animal cells. The company's CEO, David Collinson, said the bans wouldn't affect his company's research, as human clinical trials were slated to take place in the US.

"There have been half a dozen companies that have done xeno-therapy clinical studies in the US, which the FDA has given approval for in the past," he said. "We never really intended to do clinical studies in Australia or New Zealand."

LCT's DiabeCell diabetes treatment, based on the transplantation of porcine pancreatic islets, has now finished pre-clinical trials in Singapore. Primate studies are underway in Rhode Island for its NeurotrophinCell Huntington's therapy

Collinson said LCT aimed to have human clinical trials underway for both products in the second to third quarters of 2005. The company continues to conduct ongoing laboratory research in South Australia.

The NHMRC has asked its gene and related therapies research advisory panel to provide updates during the five-year moratorium on the potential benefits and risks for animal-based human treatments, and has left the door ajar for a change of heart, "should new information become available".