Exosome Therapy for Male Androgenetic Alopecia

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Male Androgenetic Alopecia

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

Study Overview

• Status: Recruiting
• Conditions: Androgenetic Alopecia (AGA)
• Intervention / Treatment: Drug: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes; Other: Normal Saline (0.9% NaCl)

Detailed Description

Androgenetic alopecia (AGA) is a chronic, progressive condition characterized by gradual miniaturization of hair follicles in a patterned distribution, primarily influenced by genetic susceptibility and androgen-mediated signaling pathways. The condition involves disruption of the hair cycle, particularly shortening of the anagen phase and progressive conversion of terminal hair follicles into vellus-like follicles, ultimately resulting in visible hair thinning and reduced hair density. In addition to its dermatological manifestations, AGA is associated with significant psychological burden, including decreased self-confidence and impaired quality of life.

Current pharmacological interventions mainly aim to slow disease progression rather than fully restore follicular function. However, their limited efficacy and dependency on continuous administration highlight the unmet need for regenerative and disease-modifying therapeutic strategies.

Mesenchymal stem cell-derived exosomes (MSC-Exos) represent a novel class of cell-free biologics with regenerative and immunomodulatory properties. These nano-sized extracellular vesicles contain bioactive molecules such as proteins, lipids, and nucleic acids, which mediate intercellular communication and regulate multiple biological processes. Among different MSC sources, human umbilical cord-derived MSCs are considered to possess advantageous biological characteristics, including higher proliferative capacity, lower immunogenicity, and more stable paracrine activity, making their exosomes particularly suitable for clinical translation.

Experimental studies have demonstrated that MSC-Exos may influence hair follicle biology through multiple complementary mechanisms, including modulation of dermal papilla cell activity, regulation of signaling pathways involved in follicular cycling, enhancement of vascular support within the perifollicular environment, and attenuation of local inflammatory responses. These combined effects may contribute to the reactivation of dormant follicles and support the transition of hair follicles into the anagen growth phase.

This clinical investigation is designed to translate these preclinical findings into a controlled human study setting, aiming to systematically evaluate the therapeutic potential of hUCMSC-derived exosomes for hair regeneration. The study will generate evidence regarding both clinical efficacy and safety profile, providing foundational data for future development of exosome-based regenerative therapies in androgenetic alopecia.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: han Zhang; Phone Number: 18510009269; Email: zhang_han_0112@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • No.28 Fuxing Road
    • Contact: han Zhang; Phone Number: 18510009269; Email: zhang_han_0112@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal Saline Injection	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.
Experimental: hUCMSC-Exosome Injection	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hair Density From Baseline to Week 12	Hair density changes within the predefined target area measured by digital trichoscopy.	Baseline to Week 12
Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 12	Assessment of global hair growth improvement using standardized photography and MGPA scoring.	Baseline to Week 12
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 24	Evaluation of treatment-related quality of life improvement using the Dermatology Life Quality Index questionnaire.	Baseline to Week 24
Change in Mean Hair Shaft Diameter From Baseline to Week 24	Mean hair shaft diameter will be measured using digital trichoscopic analysis.	Baseline to Week 24
Change in Hair Type Proportions From Baseline to Week 24	Percentage changes in vellus hairs, intermediate hairs, and terminal hairs within the target scalp area.	Baseline to Week 24
Subject Satisfaction Score at Week 24	Participant-reported satisfaction regarding overall hair growth improvement and treatment outcomes.	Week 24
Investigator Satisfaction Assessment at Week 24	Overall investigator-rated assessment of treatment response and cosmetic improvement.	Week 24

Collaborators and Investigators

• Sponsor: Zhang Han

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Mesenchymal Stem Cells; Androgenetic Alopecia; Exosomes; hUCMSC-Exos
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: PLAGH-2026-AGA-EXO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) sharing has not yet been determined. Data sharing policies will be considered after study completion in accordance with institutional regulations, ethical requirements, and participant privacy protection.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No