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 safety and efficacy 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 will involve 59 male participants aged 18 to 35. Phase I will assess the safety and optimal dosage through a dose-escalation study with 9 participants, while Phase II will compare the optimal dose of hUCMSC-sEVs to topical 5% minoxidil in 50 participants. The primary endpoint is the 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.