A Randomized Controlled Clinical Trial Protocol of Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles for the Treatment of Androgenetic Alopecia in Young Males

This study outlines a randomized controlled trial protocol to evaluate the efficacy and safety of human umbilical cord mesenchymal stem cell-derived small extracellular vesicles (hUCMSC-sEVs) for treating androgenetic alopecia (AGA) in young males. Conducted at Shenzhen People's Hospital, the trial involves 59 male participants aged 18 to 35. Phase I focuses on dose-escalation with 9 participants to determine the optimal dose, while Phase II compares the optimal dose of hUCMSC-sEVs with topical 5% minoxidil in 50 participants. The primary endpoint is safety and change in terminal hair count/cm² at 24 weeks, with secondary outcomes including hair density, shaft diameter, and patient self-assessment. This trial aims to establish a novel regenerative treatment for hair restoration in young men with AGA.