Untested, unproven, and unethical: the promotion and provision of autologous stem cell therapies in Australia

Abstract

An increasing number of private clinics in Australia are marketing and providing autologous stem cell therapies to patients. Although advocates point to the importance of medical innovation and the primacy of patient choice, these arguments are unconvincing. First, it is a stark truth that these clinics are flourishing while the efficacy and safety of autologous stem cell therapies, outside of established indications for hematopioetic stem cell transplantation, are yet to be shown. Second, few of these therapies are offered within clinical trials. Third, patients with chronic and debilitating illnesses, who are often the ones who take up these therapies, incur significant financial burdens in the expectation of benefiting from these treatments. Finally, the provision of these stem cell therapies does not follow the established pathways for legitimate medical advancement. We argue that greater regulatory oversight and professional action are necessary to protect vulnerable patients and that at this time the provision of unproven stem cell therapies outside of clinical trials is unethical.

Australasian College of Sports Physicians—position statement: the place of mesenchymal stem/stromal cell therapies in sport and exercise medicine

“…The use of autologous MCSs for the treatment of musculoskeletal conditions is currently unproven, and therefore has not yet been determined to be safe or efficacious for clinical use and there is a lack of credible long-term data to support clinical application 21 114 115 118 119. Some of the risks and burdens associated with MSC use are well recognised as they arise by virtue of their route of administration (including injection-site infection, and wrong-site administration) 21 112.…”

“…Some clinics have overstated claims about the efficacy and safety of MSCs given the current knowledge 75 115 116 119 121. Concern has also been raised about the high cost of care, the potential conflicts of interest clinicians might have, and the claims made in advertising given the absence of proven therapeutic benefit.…”

“…Concern has also been raised about the high cost of care, the potential conflicts of interest clinicians might have, and the claims made in advertising given the absence of proven therapeutic benefit. Calls have been made for this area to be more stringently regulated 21 115 116…”

“…As the state of knowledge currently held about MSCs for musculoskeletal conditions is limited, offering this intervention beyond a clinical research trial would be considered to be innovative treatment 21 106 115 116. Innovative therapies are new or modified treatments undertaken in the best interests of the patient but with as yet unproven outcomes.…”

Marketing of unproven stem cell–based interventions: A call to action

“…Such practices first emerged in the peripheries of international biomedical research and development 4 , but providers have been making inroads in some leading global markets, including Japan 5 , Australia 2,6 , and the United States 1,7 . Public warnings by scientific and medical groups 8,9 , government organizations 10 , and the media 11 Efforts to ensure that stem cell-based interventions rest on a foundation of scientific evidence have not all been in vain.…”