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Stem Cell Treatments & Regulation – a quick guide for consumers

The Therapeutic Goods Administration (TGA) has just released ‘Stem cell treatments and regulation – a quick guide for consumers.’

As the TGA states, “The science of stem cells is an exciting area of ongoing medical research with great potential. Medical research into stem cells is still at the very early stages. Our understanding of the risks associated with stem cell treatment is limited. Further research is required to create safe and effective treatments.”

People with osteoarthritis (OA) who are considering stem cell therapy should also read the position statement below by the Australian Rheumatology Association (ARA). It states:

  • Osteoarthritis is a leading cause of pain and disability for the Australian population, particularly in the elderly.
  • There is currently no disease modifying therapy that has a credible evidence base for osteoarthritis and this represents a major challenge for rheumatologists and researchers in rheumatology.
  • Cell based therapies are a promising treatment strategy that merit basic and clinical research leading to properly conducted randomised controlled trials.
  • Autologous Cell Based Interventions (ACBIs) involve the collection and administration of a patient’s own cells. In certain conditions, for example burns victims and haematological malignancies there is good evidence of clinical efficacy. For osteoarthritis, this most commonly involves harvesting fat cells, purifying, stimulating and re-injecting them into the osteoarthritic joint. At this point, there is no high quality evidence base to be confident of the safety and efficacy of this treatment.
  • Stem cell treatments/ACBIs by their nature are complex and may involve variations in the cells used, the conditions under which the cells are handled, the matrix that supports the cells and the (growth) factors used to stimulate cells, thus carefully controlled trials and long term observational studies are indicated.
  • The International Society for Stem Cell Research (ISSCR) has issued a statement that “When a professional consensus on the safety and therapeutic value of a treatment is lacking, the ISSCR believes it is unethical and unprofessional to market such interventions directly to patients”.The ARA supports this statement.
  • At this point the ARA recognizes the need for ongoing research in the area of stem cell/cellular regenerative treatments.
  • There is currently not enough supportive evidence to recommend stem cell therapy/ACBIs as a clinical intervention for osteoarthritis outside of a clinical trial setting.
  • Non-evidence based treatments and particularly therapies that involve significant cost to the patient and pose harm, should be discouraged.

Arthritis Australia is currently part of a research group looking at how Australia should regulate the increasing use of autologous adult stem cell therapies in a way that protects vulnerable people without overly restricting the clinical freedom of innovative, responsible practitioners and patients who want to be part of such innovation. More information can be obtained by visiting


Department of Health Therapeutic Goods Administration


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