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

NCT07373054 | Recruiting DMC

• 1 other identifier: 2025KY611
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Androgenic Alopecia; stem cell; exosome

Outcome Measures

Primary Outcomes (4)

• Hair Density in the Alopecia Area

  Trichoscopic hair count (hairs/cm²) in a fixed 1 cm² frontal/vertex scalp area.

  Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment

• Mean Change in Hair Shaft Diameter

  The diameter of at least 20 randomly selected terminal hairs in the alopecia area will be measured using trichoscopy with integrated measurement software, and the mean value will be calculated,Unit of measure: micrometer (μm).

  Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment

• Vellus-to-Terminal Hair Ratio

  Within a standardized alopecia area , vellus hairs (diameter \< 30 μm) and terminal hairs (diameter ≥ 30 μm) will be counted separately via trichoscopy,Their ratio will be calculated. This is a dimensionless value reported as a ratio (e.g., 0.5) or a percentage (e.g., vellus hair proportion of 50%).

  Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment

• Photographic Hair Density Score

  Standardized photographs (90-degree vertex and 45-degree frontal views) are taken under fixed conditions. A trained, blinded rater will assign a score based on a predefined photographic scale that correlates with hair density (e.g., 1=Sparse to 5=Dense).

  Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment

Secondary Outcomes (4)

• Physician Global Assessment

  Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment

• Patient Satisfaction Evaluation

  Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment

• Adverse Events Monitoring

  Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment

• Visual Analog Scale (VAS) for Pain

  Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment

Study Arms (3)

Minoxidil Treatment Group

ACTIVE COMPARATOR

Drug: Topical Minoxidil

Combination Treatment Group (Traditional)

ACTIVE COMPARATOR

Procedure: Electric Microneedling; Biological: Traditional Exosome Lyophilized Powder

Combination Treatment Group (Innovative)

EXPERIMENTAL

Procedure: Electric Microneedling; Biological: Innovative Exosome Lyophilized Powder

Interventions

Traditional Exosome Lyophilized Powder BIOLOGICAL

A solution of exosomes (3 mL) prepared using the traditional purification process, for topical application after microneedling.

Combination Treatment Group (Traditional)

Innovative Exosome Lyophilized Powder BIOLOGICAL

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.

Combination Treatment Group (Innovative)

Topical Minoxidil DRUG

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.

Minoxidil Treatment Group

Electric Microneedling PROCEDURE

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.

Combination Treatment Group (Innovative); Combination Treatment Group (Traditional)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male, aged 18 to 60 years (inclusive), in good general health.
• Clinical diagnosis of androgenetic alopecia (AGA) according to the 2023 Chinese Clinical Practice Guideline: Diagnosis and Treatment of Androgenetic Alopecia, with a disease duration of less than 5 years and a Hamilton-Norwood scale classification of stage II to IV at the screening visit.
• Able to fully understand the study's content, procedures, potential benefits, and risks, and willing to provide written informed consent prior to any study-specific procedures.
• Agrees to comply with the study protocol and refrain from using any other treatments for alopecia for the duration of the study.

You may not qualify if:

• Unwilling or unable to provide written informed consent.
• History of any malignancy within the past 5 years (except for adequately treated non-scalp basal cell carcinoma or squamous cell carcinoma in situ).
• Hypotension (blood pressure \< 90/60 mmHg) documented within 1 month prior to screening, or uncontrolled hypertension within 3 months prior to screening (defined as failure to achieve a target of \< 140/90 mmHg while on a stable regimen of at least two antihypertensive medications).
• Known history of any systemic disease that may affect hair growth or confound study assessments (e.g., HIV infection, connective tissue disease, inflammatory bowel disease, hypothyroidism, iron deficiency anemia, malnutrition, syphilis).
• Known history of other forms of non-androgenetic alopecia (e.g., diffuse alopecia, alopecia areata, cicatricial alopecia).
• History of major organ dysfunction, significant autoimmune disease, or immunodeficiency.
• Known coagulation disorders, current use of anticoagulant or antiplatelet therapy (except low-dose aspirin), thrombophilia, or inherited bleeding disorders.
• Treatment with chemotherapy, cytotoxic drugs, scalp radiation, or laser/surgical hair restoration within 12 months prior to screening.
• History of hair transplantation, or need for long-term use of wigs, hairpieces, or hair bonding agents during the trial.
• History of severe or multiple drug allergies, atopy, known allergy to local anesthetics, or planned desensitization therapy during the study period.
• Presence of any active dermatological condition in the target scalp area that could interfere with evaluation (e.g., infection, seborrheic dermatitis, psoriasis, eczema, folliculitis, open wounds, scars, or atrophy).
• Participation in another interventional clinical trial within 4 weeks prior to screening (except for non-interventional studies or participants who only signed the informed consent form without receiving any investigational product).
• Any other medical or psychiatric condition that, in the judgment of the investigator, would compromise the subject's safety, compliance, or suitability for study participation.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Affiliated Union Hospital of Fujian Medical University

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

xiaosong chen

CONTACT

+86 13365910035; chenxiaosong74@163.com

Ting Wang

CONTACT

+86 17859556387; wangting1022@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 28, 2026
• Study Start: November 6, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2025-10

Locations

CN (1)