Background: The regenerative properties of exosomes make them especially appealing to treat skin and hair diseases. Preclinical studies suggest that exosomes may fuel hair growth by stimulating dermal papilla cells, activating hair follicle stem cells, and promoting angiogenesis. However, very limited data are available on the safety and efficacy of exosome use in human subjects.
Objective: To review the published literature on exosome use in human subjects with a focus on safety and the challenges facing clinical implementation in the treatment of androgenetic and nonscarring alopecias.
Materials and methods: A review was conducted of PubMed, EMBASE, and Cochrane databases and included 48 studies. Twenty-five studies were clinical trials, 14 case reports, 4 case series, 1 retrospective review, and 4 conference abstracts.
Results: Nine clinical studies were found relevant to alopecia. One hundred twenty-five patients received an exosome treatment for hair loss. Side effects were rare. However, in the broader field of dermatology, at least 10 serious adverse events have been reported.
Conclusion: Although exosomes have many promising therapeutic applications, there is demand for larger well-designed clinical trials with extended follow-up periods to prove efficacy and a need for consistent manufacturing standards and regulatory oversight to ensure product safety.