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Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia
Sponsor: Fujian Medical University Union Hospital
Summary
Androgenic Alopecia(AGA) is a highly prevalent condition for which existing pharmacological and surgical interventions present limitations and side effects, creating a clinical need for safer and more effective therapies. In response, human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) have emerged as a cell-free therapeutic strategy. Characterized by their rich bioactive components, absence of tumorigenic risk, and high safety profile, hUCMSC-Exos represent a promising approach for hair regeneration. This study aims to evaluate the safety and efficacy of hUCMSC-Exos combined with automated microneedle delivery for treating AGA. By utilizing innovative lyophilization technology to maintain exosomal bioactivity and employing precision microneedle systems for enhanced delivery, this research seeks to provide a new generation solution for androgenic alopecia treatment.
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia: A Prospective, Randomized, Controlled Clinical Trial
Key Details
Gender
MALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2025-11-06
Completion Date
2027-05-01
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
Topical Minoxidil
Following the standard treatment protocol, subjects were instructed to topically apply 1 mL of 5% minoxidil twice daily until the completion of the 3-month treatment course. Self-recorded usage of minoxidil was documented in a daily log, which was reviewed by the investigators during each treatment visit.
Electric Microneedling
Performed with a needle length of \~1.2 mm (adjusted to scalp thickness) at 100-200 Hz. The procedure is conducted in sections (e.g., forehead, vertex, temporal regions) until mild pinpoint bleeding (indicating dermal stimulation) is achieved.
Traditional Exosome Lyophilized Powder
A solution of exosomes (3 mL) prepared using the traditional purification process, for topical application after microneedling.
Innovative Exosome Lyophilized Powder
A solution of exosomes (3 mL) prepared using a novel purification process with an inner-outer bilayer membrane lyoprotection system, for topical application after microneedling.
Locations (1)
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, China