Autologous stem cell-based interventions in Australia: exploring patient experience in light of regulatory exceptionalism

Abstract

Background & Aim Over the last decade there has been a growing prevalence of privately owned clinics in Australia providing autologous interventions to patients based on ‘stem cells’ isolated from their own fat, blood or bone marrow. These claimed stem cell-based interventions have primarily been marketed for osteoarthritis treatment, but have also been available for facial rejuvenation, hair restoration, and the treatment of motor neurone disease, Parkinson's disease and dementia. Such interventions are rarely part of a clinical research program, lack high level evidence of efficacy, and are not reimbursed by public or private insurers, resulting in patients paying significant out of pocket expenses (AUD$6,000 or more per intervention). Due to a regulatory exemption that broadly excluded the manufacturing and administration of autologous cells and tissues from the oversight of the Australian Therapeutic Goods Administration, clinics have been able to market directly and aggressively to patients in a manner that both exaggerates benefits and underplays risks. This study explores how Australian patients and their carers understood and experienced these interventions, and in particular how their presumptions about autologous stem cells, the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments. Methods, Results & Conclusion Findings were drawn from two workshops conducted in 2016 with patients, their carers and family members (22 participants) and 15 semi-structured interviews (conducted in 2017). Patients’ consideration of, and decision to undergo, an autologous stem cell-based intervention was shaped by five factors: illness experience, disillusion with current medical practice, unrealistic expectations about the intervention, lack of information from providers, and trust in the health care system and clinicians more broadly. While recently announced regulatory amendments may in time provide greater patient protection, the previous ‘light touch’ regulatory approach clearly created the preconditions in Australia for clinical practices with questionable evidentiary basis, and for a market where patient vulnerability and risk could be monetized. In future, we argue, efforts to enhance consumer awareness of the unregulated and unproven nature of autologous stem cell-based interventions need to be coupled with sound regulation and periodic policy review to avoid exceptionalism and patient exploitation.