Abstract
With the emergence of cell-based therapies as viable treatment options readily accessible to patients, the scientific community and public have raised concerns regarding consumer accessibility and regulation enforcement. Opposing viewpoints regarding regulation have emerged, and efforts to maintain the balance between promoting scientific innovation and ensuring public safety has proved challenging. To further complicate matters, there is contradictory information regarding the clinical safety and efficacy of cell-based treatments. Herein, we outline the FDA's regulatory framework for cell-based therapies and describe what we term the cutting edge, bleeding edge, and off the edge interventions. We conclude with a new classification system for regenerative cell-based therapies intended to further aid in delineating between the clinically and scientifically sound therapies to those that compel further scientific investigation.