The global regulatory landscape of stem cell medical aesthetics: challenges, comparisons, and pathways to coordination

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

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 approva

Evidence level

Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.

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