A growing concern about the use of unproven autologous stem cell therapies to treat a wide range of conditions such as osteoarthritis has led the TGA to consider tightening its regulations.
In a consultation paper published on Tuesday the TGA says concerns centre around the safety of the products, lack of evidence to support their efficacy, the cost to patients when treatment is unproven, inappropriate advertising and a lack of mechanisms for reporting adverse events.
In recent years, the number of companies and medical clinics offering services involving the use of ‘autologous stem cells’ that are not regulated under the Therapeutic Goods Act has increased, the document notes.
“This includes some companies that have developed business models designed to limit the regulatory oversight of the products they use,” it says.
The paper presents five options, one of which is classifying autologous cells as biologicals. Under this option companies would be required to:
- not advertise direct to the public
- ensure the products are safe and for homologous use only
- manufacture using ‘minimal manipulation’
- Comply with adverse event reporting.
Submissions should be received by close of business Tuesday 3 March 2015.