Australia’s National Health and Medical Research Council (NHMRC) has recommended lifting a five-year moratorium on clinical trials involving animal to human transplantation (xenotransplantation).
The decision was welcomed by Living Cell Technologies (LCT), a company based in New Zealand that develops pig cell therapies for diabetes and neurological disorders. LCT now hopes to bring its technologies and clinical trials to Australia.
The NHMRC recommended in 2004 against any xenotransplantation trials in Australia, subject to review in December 2009. That decision reflected concerns about animal viruses transferring to humans along with transplanted cells, tissues or organs.
Explaining its revised position, the Council cited developments in science and technology since 2004, “in particular evidence relating to the risks of transmission of animal viruses”, and said it “considers that the risks, if appropriately regulated, are minimal and acceptable given the potential benefits”.
The decision also took into account evidence available on the safety of xenotransplantation for individuals and the wider community, as well as emerging international guidance on the management and regulation of xenotransplantation, such as the Changsha Communiqué issued by the World Health Organization in November 2008 and guidelines developed by the European Medicines Agency.
While acknowledging the “differences of opinion in the community regarding the acceptability of xenotransplantation”, the NHMRC Council recommended that clinical trials should be allowed to proceed in Australia once:
– The Therapeutic Goods Administration had implemented “a robust framework to regulate clinical trials involving xenotransplantation”
– A “robust standard of oversight and monitoring” had been established for these procedures – to include, for example, a surveillance strategy and a patient register
– The NHMRC had issued, drawing on the advice of its Australian Health Ethics Committee and Animal Welfare Committee, guidance for researchers and ethics committees involved in animal-to-human studies
LCT is already running a Phase II trial in New Zealand and a Phase I/IIa study in Russia with its lead product, DIABECELL, for Type 1 diabetes. The company is also collaborating with the Bionic Ear Institute in Melbourne, Australia on a pilot project in animals involving its NTCELL product, noted chief executive officer Dr Paul Tan.
NTCELL comprises encapsulated porcine choroids plexus cells, which LCT says has restorative properties in neurodegenerative conditions such as deafness, Parkinson’s disease and dementia.
The company now looks forward to having “discussions with regulatory authorities around protocols for bringing our platform technologies and trials to Australia”, Dr Tan commented.
DIABECELL consists of encapsulated porcine insulin-producing cells, which can be administered without recourse to immunosuppressive drugs. The cell therapy is designed to normalise blood glucose levels in Type 1 diabetes.
