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

NCT07373054 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Androgenic Alopecia

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.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-06
Primary Completion
2026-07-01
Completion
2027-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373054 on ClinicalTrials.gov