The practice of private Stem Cell clinics in Australia

Even though stem cell science is at a relatively early stage and there are limited mature clinical data, adult stem cell therapies are already being provided directly to patients in private clinics across Australia. The study identified 17 private clinics and three stem cell companies that currently provide autologous adult stem cell therapies. These clinics offer autologous stem cell therapies for a wide range of diseases outside of clinical trials, including OA and musculoskeletal pain; neurodegenerative disorders such as muscular dystrophy and MS; stroke; retinal neuropathy; spinal cord injury; headache and migraine; asthma; autism; ‘facial rejuvenation’; and anti-aging. The medical professionals who provide stem cell therapies in these private clinics in Australia include cosmetic surgeons, sports medicine physicians, orthopedic surgeons, and general practitioners, and specialists in the diseases being treated in these clinics, such as neurologists, generally are not involved in the provision of care. Most of these clinics have websites with detailed information regarding treatments available, media coverage of the clinic, health professional profiles, and the cost of treatment.
Seven of these clinics claim to participate in research regarding stem cell therapies. However, with one exception, the health professionals at these clinics appear not to have published their findings in peer-reviewed journals. On their websites and in media interviews, both the clinics and the health professionals who provide stem cell therapies frequently make claims about efficacy and safety that cannot be supported by published evidence.
In Australia, the regulation of therapeutic goods, including prescription, non-prescription, and complementary medicines as well as medical devices, is overseen by the Therapeutic Goods Administration (TGA). The TGA regulates cell products, including blood products, vaccines, and hematopoietic stem cells, used in allogeneic transplantation. However, the TGA has specifically excluded from its regulatory jurisdiction human cells that are collected from a patient who is under the clinical care and treatment of a registered medical practitioner if the cells are manufactured by that medical practitioner for therapeutic application in a single treatment. Consequently, any registered medical practitioners in Australia can offer autologous stem cell therapy to patients for a single treatment or disease, such as OA, completely outside of any form of regulation by the TGA.