A scoping review published in Cureus in March 2025 has examined the extent and type of evidence in current literature on the use of exosomes as a treatment for hair loss. 

Exosomes are nano-sized extracellular vesicles that play a crucial role in intercellular communication by transporting bioactive molecules such as proteins, lipids, and RNA. They exert their effects on hair follicles by activating dermal papilla cells, modulating pathways to promote hair follicle development, reducing inflammation and enhancing angiogenesis.  

The U.S. Food and Drug Administration (FDA) currently classifies exosomes as biological drugs, and no exosome products have received FDA approval for hair loss treatment.  The FDA has issued warnings about unapproved exosome therapies due to reports of complications, underscoring the need for rigorous clinical testing and regulatory oversight. 

Researchers conducted a broad literature search that yielded 1,087 citations. After removing 284 duplicates, 803 articles were screened for eligibility.

Ultimately, 16 studies met the inclusion criteria for the review. These studies investigated exosome applications across various regenerative contexts, including hair follicle regeneration, wound healing, spinal cord injury repair and collagen regeneration.  

Exosomes were sourced from mesenchymal stem cells, human adipose-derived stem cells, macrophages and human dermal fibroblasts.  

Of note, 14 out of the 16 studies utilised microneedle patches, highlighting a growing consensus around this method’s efficiency in localised, minimally invasive delivery. Compared to standard injection or topical methods, microneedle-mediated delivery demonstrated superior tissue penetration and retention. 

The review positions microneedle patch delivery of MSC-derived exosomes as the leading candidate for clinical translation in hair restoration therapies. It details how they show promising results in stimulating the anagen phase, improving hair density, and promoting vascularisation around hair follicles. 

While definitive large-scale clinical trials are still lacking, the growing body of preclinical and early-phase clinical evidence makes a strong case for further exploration. It should be noted that human-derived exosomes are banned from use under EU and UK regulations.