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Regulation of stem cell treatments: information for practitioners

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Some health practitioners offer stem cell treatments as a therapeutic or cosmetic treatment for their patients. The TGA is concerned that some practitioners may be offering treatments that are unproven, illegal and potentially harmful. The TGA has increased oversight of this industry with penalties enforced for non-compliance. This protects consumer health and safety as well as the reputations of legitimate clinics and practitioners. It also encourages clinical innovation.

On this page: Why is there TGA regulatory oversight? | Pathways for accessing or providing stem cell treatments for your patients | Requirements for practitioners under the TGA regulations for stem cell treatments | Useful links

Why is there TGA regulatory oversight?

The regulatory provisions for autologous human cell and tissue (HCT) treatments such as stem cell treatments in Australia are designed to:

  • differentiate legitimate practitioners offering evidence-based clinical treatments from unscrupulous business practices offering costly, unapproved and unproven therapies
  • protect patients from potentially harmful treatments
  • allow continued access to cell therapies that have sufficient clinical evidence to demonstrate safety and efficacy
  • encourage a prescriber-patient relationship in determining the most appropriate treatment for a patient's condition.

Pathways for accessing or providing stem cell treatments for your patients

Under the regulations, stem cell products can only be provided if the regulatory requirements of one of the following pathways are met.

  • TGA Approved products: A product is approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). This product may be used by appropriately qualified practitioners for suitable patients, as per the approved clinical use.
  • Product manufacture for treatment within a hospital: Medical and/or dental practitioners may process and administer certain types of stem cell treatments in a hospital where criteria for excluded products are met. These products do not have TGA oversight.
  • Supply outside of hospitals: This is very limited. To meet the exemptions from TGA requirements, the product would need to be prepared using very minimal processing (termed 'minimal manipulation'). These products must still meet certain TGA requirements. Most stem cell products do not meet this criterion.
  • Clinical trials: Products may be offered under registered clinical trials, which means that a patient's informed consent for the experimental or investigational treatment is sought prior to offer. Generally, patients are not charged for these treatments, and the manufacturing facility for these products must satisfy good manufacturing practice (GMP) requirements and be licenced by the TGA.
  • Compassionate supply: The Special Access Scheme and Authorised Prescriber pathways are available for access to unapproved products in patients who are critically ill, or for whom no other treatment is suitable.

The graduated regulatory oversight of stem cell treatments offered by practitioners is commensurate with the safety risks posed by these treatments. For example, the administration of stem cell treatments in hospitals under the supervision of a registered medical and/or dental practitioner is excluded from TGA oversight due to the already-existing governance standards found within hospitals. By contrast, private clinics operating outside hospitals are regulated by the TGA depending on the complexity in manufacturing or processing of their cell therapies and the degree of risk that the treatment poses to patients.

Requirements for practitioners under the TGA regulations for stem cell treatments

Adverse event reporting

Medical and/or dental practitioners administering stem cell treatments are required to report any adverse events that occur during or after treatment to the TGA. This will help to establish a safety profile for such treatments, which is essential for clinical innovation. The reporting of adverse events to the TGA is standard practice for therapeutic goods (e.g. prescription medicines, medical devices) and plays an important role in monitoring their safe use in Australia.

Important risks to consider

The following adverse events have been reported as a consequence of stem cell treatments. All adverse events that occur during or after the administration of a stem cell treatment should be reported to the TGA, including but not limited to any events listed below:

  • tumors
  • abnormal bone growth
  • infection
  • allergic reaction
  • immunological adverse events.

Advertising

All HCT products, including stem cell treatments, must comply with the advertising requirements for patients. Autologous HCT products, including stem cell treatments, cannot be advertised.

If you become aware of any potential advertising breaches, please report them to the TGA.

Other regulatory oversight

The TGA is responsible for regulating therapeutic goods including stem cells. However, the TGA does not regulate clinical practice. The following regulatory bodies may have additional requirements relating to stem cell treatments:

  • Australian Health Practitioner Regulation Agency (AHPRA)
  • state, territory and national medical and dental boards or councils
  • state and territory management and administration of public hospitals
  • state and territory licensing of private hospitals
  • the Australian Competition and Consumer Commission (ACCC).

Further information about stem cell treatments is available from the following websites:

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

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