Last updated November 8, 2017 at 11:50 am
Unproven stem cell therapies will face greater scrutiny and regulation in Australia as the Therapeutic Goods Administration (TGA) responds to longstanding concerns over the lax regime in the country.
Autologous human cell and tissue products will now “be subject to regulation as biologicals by the TGA,” the agency announced in a media release.
The regulation will apply to stem cell treatments where the stem cells are taken from the person they are to be used on – autologous stem cells.
The cells go through various stages of treatment or processing with the complexity dependant on the level of alteration decided on by the clinic.
Until now, these treatments have not been subject to approval by the regulatory body because it was seen as an extension of medical practice for doctors to use a person’s own tissues for injury repair and related practices.
The changes come after two public consultations in 2016, which sought submissions from peak industry bodies, academic institutions, hospitals and various experts in health care.
Most health professionals, lawyers and stem cell experts have welcomed the regulation.
Stem cell treatments carry safety risks while promises of “miracle cures” by some private clinics with little or no scientific evidence, have also caused concern.
A quick Google search of stem cell treatments shows many sites advertising cures and miracles accompanied by tempting patient testimonials. However, unregulated stem cell treatments have resulted in permanent damage, injury, and even death.
Compounding the problem, patients with very serious illnesses like cancer and Multiple Sclerosis may shy away from proper treatment from doctors and experts.
Stem cell treatments do have the potential to change lives, and there is a push for Australian researchers to be part of the stem cell revolution. Stem cell transplants are recognised as a treatment for those with blood cancers, often in combination with chemotherapy and other drugs. There’s a growing trend for use in heart repair as well, with varying levels of success.
Under the new regulations, treatments through legitimate clinical trials will still be permissible through hospital clinics and scientists.
The proposed changes will commence in early 2018.
The approach will bring Australia into closer alignment with international regulation such as in the United States and the European Union.
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