Tough new TGA regulations on stem cell treatment have come into effect aimed at discouraging its use in commercial clinics for unproven indications such as osteoarthritis.
The new rules that came into effect on 1 July apply to providers of cell and tissue products who operate outside of hospitals, and will apply criminal penalties on those that fail to meet TGA’s requirements for safety, quality and effectiveness of biological products.
The new rules also ban consumer advertising of unproven autologous stem cell treatments and other tissue and blood products, but allow clinics to advertise the general services they provide.
According to the TGA, the new regulations do not apply to established uses of stem cells such as in relation to bone marrow transplants, and when provided by specialists in hospital settings.
The severity of regulation will depend on the degree of evidence available to support the efficacy and safety of stem cell therapy for a particular indication, and also the location, the TGA said.
“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,” it said.
Access to stem cells treatment for less well-established indications may still be possible via TGA approved pathways where the treatment is provided by a specialist in a hospital setting, as part of a clinical trial or via the Special Access pathway for people who are very sick or for whom established treatment options are unsuitable.
A spokesperson for Macquarie Stem Cells, a Sydney-based clinic that has advertised autologous stem cell therapy for osteoarthritis and rheumatoid arthritis told the limbic that the clinic would continue to operate under new TGA rules.
“The requirements are onerous but we believe we can meet them,” the spokesman said.
The company is building a new GMP level laboratory to meet TGA manufacturing standards and a separate laboratory for research purposes. It is also applying to provide stem cell therapy for OA patients as part of a clinical trial.
“We will continue treating patients for OA and joint injuries,” the company says in a statement on its website.