News

Call for regulatory change to curb unethical, exploitative and potentially hazardous practices

07 October 2016
Australian clinics and businesses continue to offer unproven, costly, and potentially hazardous medical treatments that claim to use stem cells.  There is an urgent need for more stringent regulatory oversight to protect the Australian public and overseas visitors from harm, and to ensure genuine efforts to translate promising stem cell research into clinical benefit are not stymied.

In response to concerns raised by Stem Cells Australia and others, the Therapeutic Goods Administration (TGA) is considering whether current Australian regulations on cell therapies using the patient’s own cells should be amended.  The TGA recently issued a discussion paper inviting public comment on possible options for changes to the regulations. This is the second consultation undertaken by TGA about this issue.

In a submission lodged on behalf of Stem Cells Australia, Professor Martin Pera and Associate Professor Megan Munsie have called for urgent action to address what is seen as a regulatory loophole.

Under regulations introduced in 2011, all autologous cell-based therapies – where the cells are taken from the patient for his or her own use – are exempt from manufacturing standards and safety and efficacy assessment.  This exemption applies, even if the cells are subject to extensive modification in the laboratory, and are administered to carry out tasks very different to their normal function in the body.  Such applications of cell therapy are completely experimental, and their risks and benefits are largely unknown. 

Treatments are expensive – costing from $6,000 up to allegedly $100,000 per treatment – and often promoted on websites with convincing yet unsubstantiated claims.

Commenting on this situation, Professor Pera - Program Leader of Stem Cells Australia – said, “With no formal monitoring mechanism in place, it remains impossible to accurately quantitate the extent of the ‘industry’, the number of Australian and overseas patients ‘treated’ and the extent of adverse events - or for that matter, benefit. Novel unproven stem cell treatments should only be offered in the context of a carefully conducted clinical trial, with adequate monitoring and follow-up of patients, and transparent reporting of outcomes.” 

The possibility of harm – physical, psychological and financial – to those who pursue unproven autologous interventions is real. The recent NSW Coroners Court findings, relating to the death of a woman following complications from an unfounded autologous cell intervention for her dementia, highlight the reality of the situation and the need for “legal protection against the exploitation of severely and chronically ill people by purveyors of scientifically dubious ‘therapies’”.

Associate Professor Munsie added, “The unbridled growth of providers and clinics marketing unproven ‘stem cell’ treatments clearly illustrate the current deficiencies in the Australian regulatory framework. Failure to apply rigorous standards has opened the door to  unethical, exploitative, and potentially hazardous practices.”

Stem Cells Australia’s call for greater regulatory oversight of unproven autologous cell therapies is shared by leading international scientific and research organisations such as the International Society for Stem Cell Research, the International Society for Cellular Therapy, the Australian Academy of Science and the Australasian Society for Stem Cell Research.

The TGA public consultation closed on 6 October 2016. 

Click here to read the full Stem Cells Australia submission.