Stem cell treatments on the agenda

The increasing availability of unproven stem cell therapies is beginning to be addressed with the NHMRC releasing new resources to help people navigate this complex area.

Stem cell research offers great potential to treat and repair numerous injuries and diseases. However, treatments are often reported to be more advanced that they actually are; that is, there is a lack of scientific evidence along with a lack of appropriate safety evaluations.

The regulation of cellular therapies in Australia by the Therapeutic Goods Association (TGA) is generally pretty good. But a loophole or 'medical exemption' exists that allows clinics to offer people treatment using their own cells - so-called autologous therapy.

This medical exemption means that clinics can offer people unproven and untested autologous stem cell treatments - many of which are crude or poorly characterised tissue extracts that can cost thousands of dollars.

Late last year, the NHMRC released the new resources - Stem Cell Treatments - A Quick Guide for Medical Practitioners and Stem Cell Treatments: Frequently Asked Questions - for Australian medical practitioners and patients contemplating using stem cell-based treatment.

The documents are designed to raise awareness, support people in making informed choices about treatment options and facilitate discussions between patients and their medical practitioner. They also raise awareness about doctors in Australia selling experimental treatments using a person’s own cells and encourage those who have concerns to report medical practitioners to the Australian Health Practitioners Regulatory Agency, Australian Competition and Consumer Commission or their relevant state or territory fair trading agencies.

Proven stem cell treatments that have undergone the rigorous approval process are currently limited to certain cancers, blood and autoimmune diseases, burns and repair of the cornea of the eye. All other treatments are experimental or entering clinical trials and yet to be demonstrated as safe and effective.

The International Society for Stem Cell Research released a statement last year supporting the need for regulatory oversight of this global issue.

For more information see The Australian Stem Cell Handbook, which the NHMRC documents draw on, published by the National Stem Cell Foundation of Australia and Stem Cells Australia.