A Randomized Controlled Clinical Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Hair density
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. 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
Exclusion Criteria
- •1. Known alcohol allergy
- •Patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine, or hematopoietic system
- •Patients with other scalp diseases or hair loss diseases
- •Patients with severe mental illness and cognitive impairment
- •Patients with poor nutritional status and low immune function
- •Within 1 year, those who have used systemic corticosteroids, immunosuppressants, cytotoxic drugs, and peripheral vasodilators
- •Within 6 months, those who have used systemic or local drugs to treat hair loss, such as finasteride, minoxidil, etc
- •Within 3 months, those who have received other clinical trial drugs
- •Family genetic history or other criteria considered unsuitable by researchers
Arms & Interventions
Group A
Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10^8 particles of hUCMSC-sEV per site.
Intervention: Human umbilical cord mesenchymal stem cell exosomes (Drug)
Group B
Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10^9 particles of hUCMSC-sEV per site.
Intervention: Human umbilical cord mesenchymal stem cell exosomes (Drug)
Group C
Participants will receive one injection site for each 1 cm² of hair loss area, delivering a dosage of 1.0×10^10 particles of hUCMSC-sEV per site.
Intervention: Human umbilical cord mesenchymal stem cell exosomes (Drug)
hUCMSC-sEV treatment group
Participants will receive one injection site for each 1 cm² of hair loss area with the optimal dose of hUCMSC-sEV.
Intervention: Human umbilical cord mesenchymal stem cell exosomes (Drug)
Minoxidil treatment group
Participants will get 1 mL of minoxidil administered daily to the area of hair loss.
Intervention: Minoxidil 5% Topical Solution (Drug)
Outcomes
Primary Outcomes
Hair density
Time Frame: From the first treatment to 24 weeks.
Hair density will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Hair diameter
Time Frame: From the first treatment to 24 weeks.
Hair diameter will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Hair count
Time Frame: From the first treatment to 24 weeks.
Hair count will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Secondary Outcomes
No secondary outcomes reported