Until the efficacy of autologous stem cell therapy in knee OA is proven through randomised trials it is unethical and unprofessional to market treatment directly to patients, the ARA has said in its submission to a TGA review.
The association has called for the TGA to adopt the most stringent regulatory option proposed, which would ban advertising direct to patients and require adverse event reporting.
Its concerns lay specifically in the procedure for harvesting adipose tissue derived stem cells which involves multiple steps — harvesting, purifying cell culture, stimulating and re-injecting.
“This cannot be regarded as minimal manipulation and is therefore not in the same category as vein harvesting for coronary artery bypass grafting or skin flaps,” says the submission signed by Chair of the Therapeutics Committee Professor Julian McNeil.
Research needs to be conducted along scientific lines so that any result will stand up to scrutiny, the submission said.
“For a clinical question such as the efficacy of autologous stem cell therapy this means properly conducted randomised controlled trials”.
A submission from members of the Australian Knee Society said the use of Adipose Derived Mesenchymal Stem Cells in musculoskeletal conditions should be regarded as experimental or investigational, and all recipients should be enrolled in clinical outcome trials as part of an evidence based stepwise introduction of new technology.
“The appropriate concern of a government is that there is a lack of sound evidence to support the efficacy of a treatment that has an approximate cost at present of about $6,000 to $10,000” said the submission by the society which is made up of members from the Australian Orthopaedic Association.
It recommends the TGA adopt option two which would exclude autologous stem cells from regulation under the Act “in defined circumstances” or option three that would regulate autologous stem cells under the Act, but exempt from registration and manufacturing requirements.
To view other submissions click here.
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