Actively Recruiting
A 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
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial aims to determine the efficacy of human umbilical cord mesenchymal stem cell exosomes (hUCMSC-sEV) in treating androgenic alopecia in young men. It will also investigate the safety of hUCMSC-sEV. The primary inquiry it seeks to address is: * Do hUCMSC-sEV demonstrate efficacy in the treatment of androgenic alopecia in young men? * Do hUCMSC-sEV safely used to treat androgenic alopecia in young men? The clinical trial has two parts. The Phase I study is a dose-escalation trial. Researchers will determine the appropriate dosage of hUCMSC-sEV. The Phase II study is a randomized controlled trial. Researchers will evaluate hUCMSC-sEV against a placebo (minoxidil tincture) to determine the efficacy of hUCMSC-sEV in treating androgenic alopecia in young men. In the phase I study, participants will be categorized into three dosage groups: A, B, and C. In Group A, one injection site will be allocated for each 1 cm² of hair loss area, delivering a dosage of 1.0×10\^8 particles per site. In Group B, the dosage will be 1.0×10\^9 particles per site. In Group C, the dosage will be 1.0×10\^10 particles per site. Participants will attend the clinic at weeks 0, 2, 4, and 6 for treatment and assessments. Participants will also attend the clinic for follow-up examinations at weeks 8, 12, and 24. In the phase II study, participants will be randomly allocated in a 1:1 ratio to two groups: the hUCMSC-sEV treatment group and the minoxidil treatment group. hUCMSC-sEV treatment group: the appropriate dose of hUCMSC-sEV for the phase II study was determined based on assessments of safety, tolerability, and preliminary efficacy from the phase I study. Participants will receive one injection site for each 1 cm² of hair loss area. Participants will attend the clinic for therapy and assessments at weeks 0, 2, 4, and 6. Minoxidil treatment group: participants will get 1 mL of minoxidil administered daily to the area of hair loss for 12 consecutive weeks. All patients will attend the clinic for follow-up examinations at weeks 8, 12, and 24.
CONDITIONS
Official 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
- 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 alcohol allergy
- Severe primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine, or hematopoietic system
- Other scalp diseases or hair loss diseases
- Severe mental illness and cognitive impairment
- Poor nutritional status and low immune function
- Use of systemic corticosteroids, immunosuppressants, cytotoxic drugs, or peripheral vasodilators within 1 year
- Use of systemic or local hair loss treatments such as finasteride or minoxidil within 6 months
- Participation in other clinical trials within 3 months
- Family genetic history or other criteria deemed unsuitable by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
Research Team
J
Jianglin Zhang, Ph.D
CONTACT
Z
Zhenjun Deng, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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