Actively Recruiting
A Randomized Controlled Clinical Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
Led by Shenzhen People's Hospital · Updated on 2025-12-02
59
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of human umbilical cord mesenchymal stem cell exosomes (hUCMSC-sEV) for treating androgenic alopecia, a common form of hair loss, in young men aged 18 to 35. This clinical trial aims to determine whether hUCMSC-sEV are effective and safe for this purpose. The study includes two phases: a dose-finding Phase I and a randomized controlled Phase II comparing hUCMSC-sEV with minoxidil, a current hair loss treatment. In Phase I, participants receive injections of hUCMSC-sEV at three different dose levels, adjusted to the area of hair loss, with treatments given at weeks 0, 2, 4, and 6, followed by follow-up visits at weeks 8, 12, and 24. Phase II involves randomly assigning participants to either receive the optimal dose of hUCMSC-sEV injections at the same schedule or daily topical minoxidil applied for 12 weeks, with follow-up visits also at weeks 8, 12, and 24. Participants will attend clinic visits for treatments and assessments including measurements of hair density, hair diameter, and hair count from the first treatment up to 24 weeks. The trial monitors safety, tolerability, and hair growth outcomes over the study period. The total participation time spans approximately 24 weeks from initial treatment through follow-up assessments.
CONDITIONS
Brief Title
A Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18-35 years
- Clinically diagnosed with androgenic alopecia, Hamilton Norwood Scale III-V
- Patients who voluntarily participate in clinical trials and sign informed consent forms
You will not qualify if you...
- Known allergy to alcohol
- Severe primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine, or hematopoietic systems
- Other scalp diseases or hair loss disorders
- Severe mental illness or cognitive impairment
- Poor nutritional status or low immune function
- Use of systemic corticosteroids, immunosuppressants, cytotoxic drugs, or peripheral vasodilators within 1 year
- Use of systemic or local hair loss treatments like finasteride or minoxidil within 6 months
- Participation in other clinical trials within 3 months
- Family genetic history or other factors deemed unsuitable by researchers
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.
Duration - 24 weeks
Participants receive injections of human umbilical cord mesenchymal stem cell exosomes or daily topical minoxidil 5% to the area of hair loss.
Multiple visits during treatment period
Trial Site Locations
Total: 1 location
1
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
Research Team
J
Jianglin Zhang, Ph.D
Z
Zhenjun Deng, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here