Rogue stem cell clinics are performing risky procedures with insufficient efficacy and safety data, a report in the Bone & Joint Journal states. The current environment of stem cell-based treatments, the strategies of marketing and the difficulties in regulating these clinics, are outlined.
Despite considerable legitimate research, the range of unregulated and poorly characterised cell therapies, marketed as ‘stem cells’ are not founded on clinical evidence, discrediting this important area of research. Increasingly these clinics are USA and European based, mostly targeting orthopaedic conditions, where a lack of effective treatments drives demand.
It is reported that patients have already come to harm, including bacterial infections, paraplegia and bilateral loss of vision. Misleading marketing strategies, exaggerating potential benefits, using misleading terminology and giving the perception of scientific legitimacy, all contribute to this practice.
Although recognising the features of unproven cell therapies is essential, it is the responsibility of the regulatory authorities to guide the cell therapy community. Regulatory agencies are challenged by calls for faster access to therapies, although this may cause greater risks to patients. This need must be balanced with protecting the public against delayed effective treatment, adverse events and financial loss.
Regulators and clinicians must collaborate to develop recommendations for best practice and report illegitimate stem cell clinics.