EXOSOMES IN CLINICAL AESTHETICS: REGULATORY CHALLENGES AND STANDARDIZATION

Abstract

Exosomes have emerged as an innovative approach in clinical aesthetics, particularly within the field of regenerative medicine, due to their ability to modulate cellular processes. This study aimed to critically analyze the use of exosomes in clinical aesthetics, focusing on challenges related to the standardization of their production and regulatory gaps regarding their classification as cosmetic products or injectable biological agents. This is a critical narrative literature review, based on searches in scientific databases covering publications from 2020 to 2025. Studies addressing clinical applications, isolation and extraction techniques, quality control, and regulatory aspects of exosomes were included. The results indicate that, although there is preliminary evidence of benefits such as skin rejuvenation and stimulation of hair regeneration, significant methodological limitations still exist. There is also considerable heterogeneity in isolation, characterization, and application protocols. In addition, the lack of technical standardization and a clear regulatory framework generates uncertainty regarding the safety of their use, especially in invasive procedures. It is concluded that, despite the promising potential of exosomes in clinical aesthetics and regenerative medicine, their safe application depends on advances in process standardization, robust scientific validation, and the development of specific regulations.