The Therapeutic Goods Administration has announced that 2018 will see long-awaited reforms to the regulation of stem cell therapies in the hope of curtailing unsafe or unproven treatments, and the unethical marketing of them to vulnerable people.
The announcement follows two rounds of public consultations (in 2015 and 2016) in response to serious concerns raised by doctors, researchers and patient advocates. It also follows a coronial inquest finding a dubious stem cell treatment for dementia led to the death of a NSW woman, and a rapid proliferation of stem cell clinics offering unproven treatments for conditions including arthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. They’re even offered for ‘facial rejuvenation’.
Previously, a loop hole allowed registered medical practitioners to offer treatments using ‘autologous’ stem cells—stem cells derived from a patient’s own tissues, usually obtained from fat tissue by liposuction.
Read full TGA announcement: Regulation of autologous cell and tissue products.
While the details of the new regulations are still to be determined, it is hoped this loop hole will be closed, subjecting autologous treatments to the safety standards required of drugs and other new treatments.
The Foundation’s Science and Ethics Committee has issued a statement in response.
The Foundation is pleased to see the announcement by the Therapeutic Goods Administration (TGA) regarding regulation of autologous stem cell products used for treatment in Australia.
It addresses the current anomaly where autologous cell products—prepared from patients' own tissues for re-administration as treatments for a range of illnesses—do not have to comply with the strict standards that apply to drugs and protein products used in patients.
The proposed regulatory changes briefly outlined in the announcement will be drafted into specific and detailed regulations by the Office of Parliamentary Counsel, and submitted to Government for approval.
The important points are:
- a ban on direct advertising of stem cell ‘treatments’ (specifically ‘products’) to consumers,
- a restriction of the regulatory exemption to cell and tissue products manufactured and used in a hospital by a medical or dental practitioner for a patient in his or her care, and
- the introduction of regulations to bring products currently exempt under the TGA’s regulatory umbrella. Products previously outside this class will be subject to the more stringent requirements of the Biologicals Regulatory Framework.
Salient aspects of the review recommendations include the addition of dental practitioners to the approved user category—there is high quality research into dental applications of stem cells in Australia—and defining accredited hospitals as sites approved for stem cell treatments.
Much will depend on the details of the regulations that emerge. How will the term “accredited hospitals” be interpreted for instance? In its responses to the TGA’s consultations, the Foundation expressed particular concern over the lack of ethical review or effective capture of information about treatment outcomes, which is currently a feature of the stem cell ‘industry’.
Will we see new hospitals opened specifically to comply with the regulations, but still lacking ethical review or useful data collection? We also pointed out the lack of Good Manufacturing Practice standards that are compulsory for the pharmaceutical industry but have not been followed by current stem cell practitioners.
We are pleased that a regulatory framework is under development. We hope our deep concerns for the wellbeing of patients and their relatives will be fully addressed.
Related story: Finally, unproven stem cell clinic practices might be curtailed via The Conversation.