Study of Umbilical Cord Stem Cell Exosomes to Treat Hair Loss in Young Men with Androgenic Alopecia Randomized Trial Comparing Stem Cell Exosomes to Minoxidil Phase 1 and 2 Clinical Study for Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the use of human umbilical cord mesenchymal stem cell exosomes hUCMSC-sEV for treating androgenic alopecia, a common form of hair loss, in young men aged 18 to 35. This clinical trial aims to determine whether hUCMSC-sEV are effective and safe for this purpose. The study includes two phases a dose-finding Phase I and a randomized controlled Phase II comparing hUCMSC-sEV with minoxidil, a current hair loss treatment. In Phase I, participants receive injections of hUCMSC-sEV at three different dose levels, adjusted to the area of hair loss, with treatments given at weeks 0, 2, 4, and 6, followed by follow-up visits at weeks 8, 12, and 24. Phase II involves randomly assigning participants to either receive the optimal dose of hUCMSC-sEV injections at the same schedule or daily topical minoxidil applied for 12 weeks, with follow-up visits also at weeks 8, 12, and 24. Participants will attend clinic visits for treatments and assessments including measurements of hair density, hair diameter, and hair count from the first treatment up to 24 weeks. The trial monitors safety, tolerability, and hair growth outcomes over the study period. The total participation time spans approximately 24 weeks from initial treatment through follow-up assessments.

A Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes