Exosome Therapy for Male Androgenetic Alopecia

NCT07693244 | Recruiting Phase 2

• 1 other identifier: PLAGH-2026-AGA-EXO-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Androgenetic Alopecia; Exosomes; hUCMSC-Exos; Mesenchymal Stem Cells; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Change in Hair Density From Baseline to Week 24

  Hair density (hairs/cm²) within a predefined target scalp area will be assessed using digital trichoscopy.

  Baseline to Week 24

• Change in Modified Global Photographic Assessment (MGPA) Score From 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.

  Baseline to Week 24

Secondary Outcomes (7)

• Change in Hair Density From Baseline to Week 12

  Baseline to Week 12

• Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 12

  Baseline to Week 12

• Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 24

  Baseline to Week 24

• Change in Mean Hair Shaft Diameter From Baseline to Week 24

  Baseline to Week 24

• Change in Hair Type Proportions From Baseline to Week 24

  Baseline to Week 24

Study Arms (2)

hUCMSC-Exosome Injection

EXPERIMENTAL

Drug: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes

Normal Saline Injection

PLACEBO COMPARATOR

Other: Normal Saline (0.9% NaCl)

Interventions

Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes DRUG

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.

hUCMSC-Exosome Injection

Normal Saline (0.9% NaCl) OTHER

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.

Normal Saline Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for enrollment:
• Male subjects aged 18 to 55 years;
• Diagnosis of androgenetic alopecia classified as Norwood-Hamilton grade III-V;
• Stable pattern of hair loss for at least 6 months prior to screening;
• Willingness to refrain from using any other hair loss treatments during the study period and for 6 months after completion of treatment.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• Other types of alopecia, including alopecia areata, cicatricial alopecia, or telogen effluvium;
• Use of minoxidil, finasteride, spironolactone, or other hair growth-related medications within 1 year prior to screening;
• Receipt of platelet-rich plasma (PRP), laser cap therapy, or other scalp procedures within 6 months prior to screening;
• History of autoimmune disease, active scalp infection, coagulation disorders, or malignancy;
• Known hypersensitivity to the investigational product or any of its components;
• Inability to comply with study procedures, incomplete clinical data, or conditions that may interfere with efficacy evaluation;
• Participation in another clinical trial within the study period;
• Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.

Sponsors & Collaborators

• Zhang Han: lead

Study Sites (1)

No.28 Fuxing Road

Beijing, China

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Han Zhang

CONTACT

18510009269; zhang_han_0112@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 9, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

CN (1)