A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Male Androgenetic Alopecia
The goal of this clinical trial is to learn if local scalp injection of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) can treat androgenetic alopecia (AGA) in male patients with AGA. The main question it aims to answer is: Does hUCMSC-Exos injection improve hair regrowth compared with placebo? Researchers will compare hUCMSC-Exos injection to placebo injection to see if hUCMSC-Exos leads to superior efficacy in hair follicle regeneration, as measured by changes in hair density, hair thickness, and patient-reported outcomes. Participants will: Receive randomized, double-blinded local scalp injections of either hUCMSC-Exos or placebo Attend scheduled follow-up visits for hair assessment and safety monitoring Undergo photography, trichoscopy, and complete quality-of-life or psychosocial burden questionnaires as applicable
⁃ Participants must meet all of the following criteria to be eligible for enrollment:
• Male subjects aged 18 to 55 years;
• Diagnosis of androgenetic alopecia classified as Norwood-Hamilton grade III-V;
• Stable pattern of hair loss for at least 6 months prior to screening;
• Willingness to refrain from using any other hair loss treatments during the study period and for 6 months after completion of treatment.