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Clinical Trials in China / NCT07693244
Recruiting Phase 2

Exosome Therapy for Male Androgenetic Alopecia

NCT07693244 · tracked via the Priya Life Science China tracker
Sponsor
Zhang Han
Phase
Phase 2
Started
2026-04-30
Last updated
2026-07-09

Condition(s) studied

Androgenetic Alopecia (AGA)

Investigational drug(s) / intervention(s)

Human Umbilical Cord Mesenchymal Stem Cell-Derived ExosomesNormal Saline (0.9% NaCl)

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.

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.

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

Eligibility

Sex
MALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria Participants must meet all of the following criteria to be eligible for enrollment: 1. Male subjects aged 18 to 55 years; 2. Diagnosis of androgenetic alopecia classified as Norwood-Hamilton grade III-V; 3. Stable pattern of hair loss for at least 6 months prior to screening; 4. Willingness to refrain from using any other hair loss treatments during the study period and for 6 months after completion of treatment. Exclusion Criteria Participants meeting any of the following criteria will be excluded: 1. Other types of alopecia, including alopecia areata, cicatricial alopecia, or telogen effluvium; 2. Use of minoxidil, finasteride, spironolactone, or other hair growth-related medications within 1 year prior to screening; 3. Receipt of platelet-rich plasma (PRP), laser cap therapy, or other scalp procedures within 6 months prior to screening; 4. History of autoimmune disease, active scalp infection, coagulation disorders, or malignancy; 5. Known hypersensitivity to the investigational product or any of its components; 6. Inability to comply with study procedures, incomplete clinical data, or conditions that may interfere with efficacy evaluation; 7. Participation in another clinical trial within the study period; 8. Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.

Primary outcome measure(s)

  • Change in Hair Density From Baseline to Week 24 — Baseline to Week 24
    Hair density (hairs/cm²) within a predefined target scalp area will be assessed using digital trichoscopy.
  • Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 24 — Baseline to Week 24
    Global scalp photographs will be evaluated by blinded investigators using the Modified Global Photographic Assessment (MGPA) scale to assess overall improvement in hair growth.

Trial sites (1)

FacilityCityRegionStatus
No.28 Fuxing Road Beijing China Recruiting

Other trials for the same condition

To Evaluate Efficacy and Safety of TopicalKX-826 Solution in Chinese Male Patients With Androgenetic Alopecia Starting soon
Multi-Omics Insights Into Androgenetic Alopecia Recruiting
Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia Recruiting
Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07693244 on ClinicalTrials.gov ↗ ← All trials in China