In its submission to the TGA inquiry into the regulation of stem cells the Australian Rheumatology Association and Arthritis Australia have opted for what has been described as the most ‘rational option’ offered by the regulatory body for closing the current regulatory loophole that allows stem cell clinics to provide unproven treatments.
According to the peak professional and consumer bodies autologous stem cell therapies offer promise as a potential treatment for osteoarthritis, but properly conducted randomised controlled clinical trials were needed to determine if the treatment had a therapeutic role.
They said the current lack of regulation exposed vulnerable consumers to unproven treatment that could pose a serious health risk, without clear evidence of benefit.
The treatments were also at a “substantial financial costs to consumers”.
“For these reasons, we consider it unethical and unprofessional to market these unproven treatments to consumers and support much tighter regulation of their use by the Therapeutic Goods Administration,” they wrote.
In their view, consumers will be best protected if the TGA opt for Option 4 for the regulation of autologous cell and tissue products.
This option maintains existing exclusion for products (with a minor modification to extend to dental practitioners) provided the products are not advertised directly to consumers and not more than minimally manipulated.
As reported previously by the limbic Professor John Rasko, head of the Cell and Molecular Therapies department at the Royal Prince Alfred Hospital, and vocal proponent of closing the regulatory loophole, referred to option 4 as “the most rational reaction to closing the loophole.”
“Why should we be lowering the bar in regulation?” he said.
The ARA and AA noted that in recommending option 4, they supported the TGA view outlined in the consultation paper that: “physical disruption of a tissue such as adipose tissue, as occurs in stem cell treatments for osteoarthritis, constitutes more than minimal manipulation and hence would be regulated under the TGA Act in the same way as other biologicals.
“We also support the new definition of ‘minimal manipulation’ proposed by the TGA, which more closely aligns with international definitions. We support the consistent use of this new definition across the entire biologicals framework,” the submission said.
Click here to read the full submission.
Other options put forward by the TGA include:
Option 1 – is essentially the status quo (with a minor modification to extend to dental practitioners).
Option 2 – maintains existing exclusion for products (with a minor modification to extend to dental practitioners) provided the products are not advertised direct-to-consumers.
Option 3 – maintains existing exclusion for products (with a minor modification to extend to dental practitioners) provided the products are not advertised directly to consumers and not more than minimally manipulated, but introduces a new and increased intermediate level of regulation for products that involve more than minimal manipulation reflecting the level of potential risk.