The authors state that stem cell interventions in the US fall under the FDA’s Human Cell, Tissue, and Cellular and Tissue-Based Product regulatory framework, but note that oversight has increasingly been challenged as commercial clinics market regenerative therapies directly to consumers. 

The article highlights concerns surrounding unapproved stem cell products offered within the US market, including risks of infection, immune reactions, tumour formation and financial exploitation of vulnerable patients. 

According to the authors, maintaining strong FDA oversight is essential to distinguish legitimate clinical research and approved therapies from interventions promoted without sufficient evidence of safety or efficacy. 

The paper concludes that while stem cell medicine holds significant therapeutic potential, robust regulation remains critical to supporting patient safety, scientific integrity and long-term development of evidence-based regenerative therapies in the US.