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TGA to review advertising of stem cell therapies to the Australian public

7 April 2021

The Therapeutic Goods Administration (TGA), part of the Department of Health, is investigating the advertising of stem cell therapies to ensure that content in the public domain complies with the Australian rules for advertising therapeutic goods.

The term 'stem cell' therapies is often used to refer to autologous human cell and tissue (HCT) therapies. HCT products comprise, contain, or are derived from human cells and/or tissues. Autologous HCT products are those that are removed from, and applied to, the same person.

It is important that any decision to use a biological or HCT stem cell therapy to treat a health condition is made in conjunction with a treating health professional.

Consumers who have not found relief from the symptoms of a health condition through conventional means are especially vulnerable to claims about emerging treatments not included in the Australian Register of Therapeutic Goods (the Register). This may impact on their ability to critically evaluate whether a particular good is appropriate for them.

Due to the vulnerability of this patient group, criminal offences and civil penalties can apply under the Therapeutic Goods Act 1989 (TG Act) where a person advertises or promotes the use of HCT products to the public. This includes autologous HCT products that are exempt or excluded from being included in the Register.

If you see an advertisement for stem cells or autologous HCT products, you can submit a report to the TGA using our online form.