The therapeutic and commercial landscape of stem cell vesicles in regenerative dermatology

Extracellular vesicles (EVs) are lipid enveloped nanoparticles that are naturally produced by cells and function in the intercellular transfer of biological material such as proteins, RNAs and metabolites. They have been shown to act in an autocrine and paracrine manner to alter the functions of local and distant recipient cells, with a growing body of evidence highlighting their wide-ranging functions in regenerative processes such as stem cell maintenance, tissue repair and immune modulation. EVs offer several potential advantages over stem cell therapies such as improved safety profiles, scalability, and enhanced storage and quality control of the final product. In fact, many of the pro-regenerative outcomes of stem cell therapies have been attributed to the release of mesenchymal stem cell-derived EVs (MSC-EVs) and their potent effects on extracellular matrix turnover, local cell recruitment, proliferation and angiogenesis is now well described. These positive outcomes have led to clinical trials assessing the safety of MSC-EVs for applications in wound healing and the treatment of cutaneous ulcers, as well as the emergence of multiple commercial MSC-EV sources marketed for topical application in cosmetic medicine. However, regenerative EV therapeutics remain in their infancy and pertinent questions regarding product standardisation, potency and the regulatory landscape surrounding the development of these promising nano therapeutics must be addressed to ensure safe and effective clinical adoption. In this article we provide an overview of the emerging landscape of MSC-EVs in regenerative dermatology and cosmetic science, highlighting the underlying biological mechanisms pertinent to their application and providing a perspective on current safety considerations, regulation and future directions in the field.