Unproven stem cell interventions: A global public health problem requiring global deliberation

The unproven stem cell intervention (SCI) industry is a global health problem. Despite efforts of some nations, the industry continues to flourish. In this paper, we call for a global approach and the establishment of a World Health Organization (WHO) Expert Advisory Committee on Regenerative Medicine to tackle this issue and provide guidance. The WHO committee can harmonize national regulations; promote regulatory approaches responsive to unmet patient needs; and formulate an education campaign against misinformation. Fostering an international dialog and developing recommendations that can be adopted by member states would effectively address the global market of unproven SCIs.

Main text

The unproven stem cell intervention (SCI) industry is used to describe a worldwide, direct-to-consumer market where clinics offer stem cells, stem cell-derived components, such as exosomes and non-stem cell-based cellular products to patients with little to no scientific or clinical basis (Turner, 2020; U.S. Food and Drug Administration, 2019). The application of unproven SCIs to consumers has led to multiple patient injuries and deaths (Bauer et al., 2018), and the industry threatens legitimate research efforts (...