A growing number of clinics are offering unproven, costly, and potentially hazardous stem cell therapies in Australia. There is an urgent need for more stringent oversight to protect patients against risks, and to bring Australian regulations into alignment with other jurisdictions and the recommendations of leading international learned scientific and research organisations.
In response to concerns raised by Stem Cells Australia and others, the Therapeutic Goods Administration (TGA) is considering whether current Australian regulations on cell therapy are appropriate. The TGA recently issued a discussion paper inviting public comment on possible options for changes to the regulations.
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.
Commenting on this situation, Professor Pera - Program Leader of Stem Cells Australia - said “The current blanket exemption is unsatisfactory. Rather than encourage responsible translation through preclinical research and clinical trials, the last four years has seen an exponential growth in Australian clinics and individual doctors providing unproven and unfounded autologous interventions.”
Such treatments are expensive – costing approximately $10,000 per treatment – and often promoted on websites with convincing yet unsubstantiated claims. 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.
Professor Pera also said, “Increased regulation will not restrict innovation and development of promising new treatments in Australia, but will provide appropriate safeguards to protect the public from unfounded, potentially dangerous, and exploitative practices. It is essential that our regulations are amended immediately to ensure that all cell therapies are safe and fit for their intended purpose.”
Stem Cells Australia’s call for greater regulatory oversight of unproven autologous cell therapies is shared by groups such as the International Society for Stem Cell Research, the Australian Academy of Science, the National Stem Cell Foundation of Australia, MND Australia and the Australian Rheumatology Association.
The TGA public consultation closes on 3 March 2015.
Click here to read the full Stem Cells Australia submission.
For more information on stem cell research and its clinical application download The Australian Stem Cell Handbook.