In December 2013, the National Health and Medical Research Council (NHMRC) published two resources on stem cell treatments. The resources provide medical practitioners and patients with information on the stem cell treatments that are available, and the risks involved in undergoing unproven treatments.The resources are titled ‘Stem Cell Treatments – a Quick Guide for Medical Practitioners’ and ‘Stem Cell Treatments – Frequently Asked Questions’.
Stem cells are cells that have the potential to become a range of different cell types. The process of stem cells becoming particular cell types is called ‘differentiation’. Stem cells can also replace themselves, or ‘self-replicate’. This ability to differentiate and self-replicate is what has stimulated such enormous interest in the use of stem cells in the treatment of disease.
Reports in the media suggest that stem cell treatments are close to being available to patients to treat a wide range of diseases, and these reports influence public perception. However, further research is required to create safe and effective treatments. The reality is - other than the use of haematopoietic stem cell transplantation for blood and certain immune related disorders - the majority of stem cell treatments are still in the early stages of research and development and have not been demonstrated to be safe and effective.
An increasing number of people are travelling overseas for stem cell treatments that are unproven, often referred to as ‘stem cell tourism’. Unproven treatments using a mixture of the patient’s own (autologous) cells are also being offered by private clinics in Australia. NHMRC’s position is that new medical treatments should be tested through clinical trials to show that they are safe and effective before being made available to the public.
Unproven stem cell treatments can result in serious health complications such as infection, allergic reaction or immune system rejection and the development of cancer. In addition to the health and safety risks, these treatments often involve significant financial costs. Undergoing unproven treatments may also interfere with or delay a patient accessing proven and potentially beneficial therapies or treatment plans.
Patients considering stem cell treatments should seek additional information from a trustworthy source other than the treatment provider and speak to their general or specialist medical practitioners. Patients may wish to investigate the option of participating in a registered clinical trial rather than accessing unproven stem cell treatments offered by private clinics.
The Practitioner Resource and FAQs represent a function of the NHMRC, as provided in Section 7(1)(a)) of the National Health and Medical Research Council Act 1992, which is to inquire into and advise the community on matters relating to the improvement of health, and the prevention, diagnosis and treatment of disease.
The purpose of the Practitioner Resource and FAQs aligns with the 2013-2015 NHMRC Strategic Plan which identifies ‘claiming benefits for human health not based on evidence’ as a major health issue by advising the Australian public about the available stem cell treatments, and the risks involved in undergoing unproven treatments. The resources assist the Australian community to make informed decisions about their health care.
NHMRC’s Health Care Committee (HCC) oversaw the development of the Practitioner Resource and FAQs, adapting content from patient handbooks developed by the Australian Stem Cell Centre and the International Society for Stem Cell Research. The resources were also considered by NHMRC’s Council prior to release.
The Practitioner Resource and FAQs were released for public consultation on 22 August 2012. Public consultation was open for six weeks and closed on 4 October 2012. Ten submissions were received from a variety of organisations, including stem cell foundations and research organisations, a consumer group, a disease alliance group and a centre for ethics. HCC members advised ONHMRC on the necessary amendments to the documents following public consultation. All submissions received during the consultation were taken into consideration.
The most significant change made to the documents following public consultation was to broaden the scope of the documents to address unproven stem cell treatments offered in Australia, as well as those offered overseas. This was an issue raised in a number of submissions. Other changes made were as follows:
- the distinction between ‘proven’ and ‘unproven’ stem cell treatments was clarified and made more explicit;
- the information about risks of undergoing unproven treatments was expanded;
- the information regarding clinical trials was revised to improve its utility; and
- a glossary of stem cell related terms was added to the Practitioner Resource.