Abstract This paper systematically examines the regulatory frameworks of major regulatory bodies—including the United States, the European Union, Japan, South Korea, and China—regarding the use of stem cells and their derivatives (such as conditioned media and exosomes) for cosmetic purposes. Despite the rapid global growth of “stem cell medical aesthetics” within the cosmetic medical market, its scientific evidence remains insufficient, and it faces the core challenge of inconsistent regulatory systems. Through in-depth comparative analysis, this paper not only reveals profound differences among nations in risk perception, regulatory philosophy, and terminology definitions, but also dissects the resulting market fragmentation and patient safety risks. Based on this, the paper proposes feasible pathways to advance international regulatory coordination: The primary task is to unify core definitions and classification standards (especially for derivatives like exosomes) based on scientific consensus, and establish a risk-based tiered regulatory mechanism that clearly distinguishes medical from cosmetic applications. Concurrently, fundamental research should be strengthened and specific efficacy assessment standards (e.g., instrument measurements and patient-reported outcomes) should be developed. Crucially, this paper advocates for a hybrid regulatory model integrating conditional approval with real-world evidence tracking as a pragmatic solution balancing patient safety and technological innovation. This research aims to provide theoretical support and practical guidance for constructing a global governance framework that safeguards safety while accommodating innovation efficiency.
Xiao et al. (Mon,) studied this question.