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RECRUITING
NCT07373054
NA

Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

PROCEDURE

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.

BIOLOGICAL

Traditional Exosome Lyophilized Powder

A solution of exosomes (3 mL) prepared using the traditional purification process, for topical application after microneedling.

BIOLOGICAL

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