Regulatory, Ethical, and Safety Considerations of Exosome‐Based Therapies in Dermatology

ABSTRACT Background Exosome and stem cell–derived products have rapidly gained popularity in dermatology, particularly in elective settings. Despite their expanding clinical and commercial use, exosome‐based therapies have yet to receive regulatory approval for dermatologic indications, and long‐term safety data remains limited. Objective To review the biological background, global regulatory frameworks, safety considerations, and ethical challenges associated with exosome‐based therapies in dermatology, with an emphasis on clinical decision‐making in elective settings. Methods A narrative review of current regulatory guidance, published clinical and preclinical literature, and ethical frameworks relevant to exosome and stem cell–derived products was conducted. Results Exosome‐based therapies do demonstrate potential regenerative applications in areas such as skin rejuvenation, wound healing, and hair restoration. However, substantial variability in cell sourcing, manufacturing processes, and product characterization makes standardization and regulation complicated. No exosome‐based products have received U.S. Food and Drug Administration (FDA) approval for dermatologic use. Reported adverse reactions, limited longitudinal follow‐up, and variability in international regulatory oversight highlight persistent translational and safety gaps. Conclusion While exosome‐based therapies represent an evolving frontier in dermatology, their integration into clinical practice should proceed with caution. Regulatory literacy, transparent informed consent, structured product evaluation, and evidence‐based clinical restraint are essential to ensure patient safety.