Despite a lack of clear evidence of safety and efficacy developed under traditional clinical translation pathways for medical therapies, there has been a surge of unproven clinical uses of stem cell-based interventions, often enabled by businesses marketing these purported therapies directly to patients. This is made possible in part by the diverse regulatory and policy environments in different countries. While the desire of patients to access therapeutic interventions is completely understandable, many stand to be harmed by receiving interventions that have not been adequately tested. This possibility raises substantial ethical concerns and has the potential to diminish public trust in cellular therapies more generally, incur health care costs due to adverse events and derail research into regenerative medicines. Regulators, scientists, clinicians, professional societies and patient advocacy groups need to work collaboratively to articulate the legal and ethical expectations of stem cell-based therapies and create novel approaches to their development, translation, regulation and governance.