Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
MALE
NCT07373054

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

Led by Fujian Medical University Union Hospital · Updated on 2026-01-30

18

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 to 60 years in good general health
  • Diagnosed with androgenic alopecia (AGA) with disease duration less than 5 years
  • AGA classified as stage II to IV on the Hamilton-Norwood scale at screening
  • Able to understand study details and willing to provide written informed consent
  • Agree to follow the study protocol and avoid other alopecia treatments during the study
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide written informed consent
  • History of any cancer within the past 5 years except treated non-scalp basal or squamous cell carcinoma in situ
  • Low blood pressure (<90/60 mmHg) within 1 month prior to screening or uncontrolled hypertension within 3 months prior
  • Known systemic diseases affecting hair growth or study assessments (e.g., HIV, connective tissue disease, inflammatory bowel disease, hypothyroidism, iron deficiency anemia, malnutrition, syphilis)
  • Other types of non-androgenic alopecia (e.g., diffuse alopecia, alopecia areata, cicatricial alopecia)
  • History of major organ dysfunction, significant autoimmune disease, or immunodeficiency
  • Known bleeding disorders or current use of anticoagulant/antiplatelet therapy except low-dose aspirin
  • Chemotherapy, cytotoxic drugs, scalp radiation, or hair restoration surgery within 12 months prior to screening
  • History of hair transplantation or need for wigs, hairpieces, or hair bonding agents during the trial
  • Severe or multiple drug allergies, atopy, allergy to local anesthetics, or planned desensitization therapy during the study
  • Active scalp skin conditions interfering with evaluation (infection, seborrheic dermatitis, psoriasis, eczema, folliculitis, open wounds, scars, atrophy)
  • Participation in another interventional clinical trial within 4 weeks prior to screening
  • Any medical or psychiatric condition that may affect safety, compliance, or suitability for the study according to investigator judgment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Affiliated Union Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350001

Actively Recruiting

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Research Team

X

xiaosong chen

CONTACT

T

Ting Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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