TGA strengthens regulation of stem cell treatments

The Therapeutic Goods Administration (TGA) has strengthened the regulation of stem cell treatments in Australia. The new regulations maintain consumer access to established stem cell treatments while protecting consumers from unproven and harmful treatments. The new regulations came into force on 1 July 2019 following a one year transition period.

Stem cell treatments involve using unspecialised cells (stem cells) to replace other cells in the body that have been lost through injury or disease. Stem cell treatments have great promise for medicine, but in many cases, more research is needed to establish the risks and benefits. The TGA's approach ensures that research and innovation in this area can continue while consumer safety is protected.

The new regulations expand the TGA's oversight of stem cell treatments

In the past, the TGA excluded a broader range of treatment providers from our regulatory requirements. In response to concerns about some providers offering unproven and harmful treatments, the TGA has expanded its oversight of stem cell treatments.

Under the new regulations, all providers of cell and tissue products who operate outside of hospitals will need to meet the TGA's requirements for safety, quality and effectiveness. Providers who fail to meet the requirements may face criminal penalties.

Stem cell treatments that are offered in hospitals are likely to remain excluded from TGA regulations. It is up to the hospital to decide the suitability and safety of the stem cell treatments they may offer.

The new regulations maintain access to established stem cell treatments

Specialist doctors in hospitals routinely treat patients with cancer and blood disorders using stem cells sourced from blood or bone marrow (i.e. 'bone marrow transplants'). Under the new regulations, access to these treatments will continue unchanged.

The new regulations allow appropriate access to stem cell treatments that are less established

The amount of scientific evidence available to support the safety and effectiveness of stem cell treatments differs from one treatment to another. For example, injecting stem cells sourced from fat (adipose) tissue to treat joint pain has not yet been shown to be safe or effective. Under the new regulations, less established treatments like this may no longer be available from providers who operate outside of hospitals.

However, consumers will still be able to access less established stem cell treatments where appropriate. Pathways for accessing less established stem cell treatments include:

• treatment in a hospital following consultation with a specialist doctor
• treatment as part of a clinical trial after giving informed consent to participate
• treatment in other settings where a doctor has used a special access pathway for people who are very sick or for whom established treatment options are unsuitable.

Further information

Read the TGA's quick guide for consumers on the regulation of stem cell treatments in Australia.

Information about stem cell treatments can also be found on the Stem Cells Australia website and the International Society for Stem Cell Research (ISSCR) website, which includes a Patient Handbook on Stem Cell Therapies.

If you have further questions, please contact bloodandtissues@tga.gov.au.