Concerned by the growing number of Australian doctors selling unproven stem cell treatments, Stem Cells Australia has called for the regulations to be tightened to curb these exploitative and potentially risky practices.
In 2011 the Australian Government introduced new regulations to provide greater guidance and oversight on products made from cells and tissues.
Consistent with practice in other jurisdictions around the world, these new regulations set out standards to ensure that benefits to patients outweighed any risks.
The potential risk of cell therapy was characterised by how closely the intended use of the product matched the original biological function, and on how far removed the cells or tissue were from their naturally occurring state. The greater the degree of manipulation in manufacturing, or the greater the difference between the proposed use and what the cells or tissue usually do in the body, the more stringent the requirement, to demonstrate safety and efficacy via clinical trials prior to any treatment being approved.
However, all autologous cell and tissue-based therapies (where the cells are taken from the patient for their own use) were excluded from having to comply with these stringent standards. This exemption has had the unintended consequence of allowing clinics in Australia to market unproven stem cell treatments outside of a clinical trial framework. The number of such clinics offering unregulated cell therapies has grown substantially during the past several years. Concerned by this development, Stem Cells Australia has called for the regulations to be tightened.
Simple modifications to the current regulations - such as incorporating recognition of the inherent risks in placing cells in a different organ from which they were obtained (non-homologous use), and making it a requirement that all manufacturing and processing of cells occurs in accredited laboratories - should curb exploitative potentially risky practices without impeding medical innovation.
As highlighted by the International Society for Stem Cell Research, it should be considered unethical to market unproven cell-based interventions outside of clinical trials – even when the patient’s own cells are used.
Although it is possible under the current framework to report the conduct of individual medical and health practitioners to Australian Health Practitioners Regulation Agency for investigation, or lodge a complaint to Australian Competition and Consumer Commission, we believe the issue of unproven autologous stem cell treatments would be best addressed by tightening the wording of the current exemption.
We need, and must insist on, a strong evidence base as we translate stem cell science to the clinic.
For more information on responsible translation of stem cell science and regenerative medicine download our Australian Stem Cell Handbook, the new NHMRC resources or visit the Closer Look at Stem Cells website.