In an article published by Sipp D et al., in Science Translational Medicine, 15 experts around the world demanded a more stringent regulation to protect vulnerable patients from unproven and dangerous stem cell-based treatment.
The growth of the industry engaged in direct-to-consumer online marketing of stem cell interventions has become impossible to ignore. The growth of the Internet and social media has provided new outlets for the worldwide marketing of both licensed and unlicensed therapeutics. It also makes national regulation more complicated to be implemented in a global market place.
Indeed, providers promote the use of stem cell-based therapy for a wide range of indications even in absence of biological supporting evidences. Efficacy to justify routine clinical uses of stem cells has been defined by many professional organizations: decisions should typically be based on results from independent, randomized, controlled clinical trials. However, there is a diversity of viewpoints on the nature and quality of evidence needed to support widespread clinical adoption resulting in a gray zone left to interpretation. In Europe or US, treatment using human cell or tissue is defined as a medical product and need an oversight by the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) respectively. On the contrary, in Japan or Australia, the use of autologous cells is left at the physicians’ discretion. Additionally, providers often display tokens of scientific legitimacy in their marketing messages such as publications in journals with weak or nonexistent peer review and the registration of pay-to-participate clinical trials on public databases. It becomes extremely complicated for professionals and even more for patients to estimate the veracity of the scientific evidence supporting a stem cell therapy. The success of this industry has adverse implications for patients’ health and the integrity of health care markets.
In some cases, by mobilizing support from international scientific organizations and engaging communication with the public, researchers were able to exert a positive influence on national policies to stop the activities of clinics such as in Germany, China or Italy. Mutual engagement across a broad range of stakeholders is needed to foster regulatory frameworks that facilitate progress in medical research and ultimately affordable clinical benefit.