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Exosome Therapy for Male Androgenetic Alopecia

NCT07693244 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-09

No results posted yet for this study

Summary

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

Conditions

  • Androgenetic Alopecia (AGA)

Interventions

DRUG

Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes

Sterile exosome suspension derived from human umbilical cord mesenchymal stem cells (hUCMSC-Exos). Administered via intradermal scalp injection at 0.05 mL per point, 1 cm spacing, approximately 4 mm depth. Treatment repeated once every 4 weeks for a total of 3 sessions.

OTHER

Normal Saline (0.9% NaCl)

Sterile 0.9% normal saline injection. Administered via intradermal scalp injection using the same protocol as the experimental group: 0.05 mL per point, 1 cm spacing, approximately 4 mm depth, once every 4 weeks for a total of 3 sessions.

Sponsors & Collaborators

  • Zhang Han

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-11-10
Completion
2026-11-10

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 NCT07693244 on ClinicalTrials.gov