Actively Recruiting
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes with Automated Microneedle Delivery for Androgenic Alopecia: A Randomized Controlled Clinical Trial
Led by Fujian Medical University Union Hospital · Updated on 2026-01-30
18
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Androgenic Alopecia (AGA) is a common hereditary hair loss condition with limited current treatments that often cause side effects or have high costs and complications. Researchers are studying human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) as a new, safer option. These exosomes are tiny, cell-free particles rich in bioactive components, without tumor risks or significant toxicity, making them promising for hair regeneration when combined with advanced delivery methods. This trial compares three groups: one using standard topical minoxidil twice daily, another combining minoxidil with traditional exosome lyophilized powder applied after electric microneedling, and a third using minoxidil with an innovative exosome powder prepared by a novel lyophilization method and delivered similarly. The microneedling uses precise, automated needles for uniform scalp penetration, aiming to improve the delivery of exosomes into scalp tissues. Participants will be monitored before treatment and at 4, 12, and 24 weeks after starting. Evaluations include hair density, hair shaft thickness, hair type ratios, photographic scores, physician assessments, patient satisfaction, pain levels, and adverse event monitoring. The study runs from late 2025 until 2027, with visits scheduled to assess treatment effects and safety over this period.
CONDITIONS
Brief Title
Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 60 years in good general health
- Clinical diagnosis of androgenetic alopecia (AGA) with disease duration less than 5 years
- Hamilton-Norwood scale stage II to IV at screening
- Ability to understand study procedures and provide written consent
- Willingness to comply with study protocol and avoid other alopecia treatments during the study
You will not qualify if you...
- Unwilling or unable to provide written informed consent
- History of malignancy within 5 years except treated non-scalp basal cell or squamous cell carcinoma in situ
- Hypotension or uncontrolled hypertension within specified recent periods
- Systemic diseases affecting hair growth or study assessments (e.g., HIV, connective tissue disease, hypothyroidism)
- Other forms of non-androgenetic alopecia
- Major organ dysfunction, autoimmune disease, or immunodeficiency
- Coagulation disorders or use of anticoagulant/antiplatelet therapy (except low-dose aspirin)
- Recent chemotherapy, scalp radiation, or surgical hair restoration within 12 months
- History of hair transplantation or use of wigs/hairpieces during trial
- Severe drug allergies or allergy to local anesthetics
- Active scalp dermatological conditions interfering with evaluation
- Participation in another interventional trial within 4 weeks prior to screening
- Any medical or psychiatric condition compromising safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive treatment with topical minoxidil alone or combined with microneedling and exosome application using either traditional or innovative lyophilized exosome powders.
Visits at Weeks 0, 4, and 12 for treatment and assessment
Duration - Up to 12 weeks after treatment
Participants are monitored for safety and efficacy outcomes after treatment completion.
1 visit at Week 24 after first treatment
Trial Site Locations
Total: 1 location
1
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
X
xiaosong chen
T
Ting Wang
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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