A Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
NCT ID: NCT07203599
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
59 participants
INTERVENTIONAL
2025-09-20
2026-11-01
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Human umbilical cord mesenchymal stem cell exosomes
Human umbilical cord mesenchymal stem cell exosomes are nanoscale vesicles released by mesenchymal stem cells from the umbilical cord. These exosomes act as natural carriers, transferring proteins, microRNAs (miRNAs), and other molecules to recipient cells. This communication helps the exosomes exert therapeutic effects, promoting tissue repair, reducing inflammation, and mediating cell-to-cell interactions in various disease models.
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.
Human umbilical cord mesenchymal stem cell exosomes
Human umbilical cord mesenchymal stem cell exosomes are nanoscale vesicles released by mesenchymal stem cells from the umbilical cord. These exosomes act as natural carriers, transferring proteins, microRNAs (miRNAs), and other molecules to recipient cells. This communication helps the exosomes exert therapeutic effects, promoting tissue repair, reducing inflammation, and mediating cell-to-cell interactions in various disease models.
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.
Human umbilical cord mesenchymal stem cell exosomes
Human umbilical cord mesenchymal stem cell exosomes are nanoscale vesicles released by mesenchymal stem cells from the umbilical cord. These exosomes act as natural carriers, transferring proteins, microRNAs (miRNAs), and other molecules to recipient cells. This communication helps the exosomes exert therapeutic effects, promoting tissue repair, reducing inflammation, and mediating cell-to-cell interactions in various disease models.
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.
Human umbilical cord mesenchymal stem cell exosomes
Human umbilical cord mesenchymal stem cell exosomes are nanoscale vesicles released by mesenchymal stem cells from the umbilical cord. These exosomes act as natural carriers, transferring proteins, microRNAs (miRNAs), and other molecules to recipient cells. This communication helps the exosomes exert therapeutic effects, promoting tissue repair, reducing inflammation, and mediating cell-to-cell interactions in various disease models.
Minoxidil treatment group
Participants will get 1 mL of minoxidil administered daily to the area of hair loss.
Minoxidil 5% Topical Solution
Topical minoxidil is a medicine used to help regrow the hair on your scalp. It works by increasing the blood flow to your hair and helps stimulate your hair follicles to grow.
Interventions
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Human umbilical cord mesenchymal stem cell exosomes
Human umbilical cord mesenchymal stem cell exosomes are nanoscale vesicles released by mesenchymal stem cells from the umbilical cord. These exosomes act as natural carriers, transferring proteins, microRNAs (miRNAs), and other molecules to recipient cells. This communication helps the exosomes exert therapeutic effects, promoting tissue repair, reducing inflammation, and mediating cell-to-cell interactions in various disease models.
Minoxidil 5% Topical Solution
Topical minoxidil is a medicine used to help regrow the hair on your scalp. It works by increasing the blood flow to your hair and helps stimulate your hair follicles to grow.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
35 Years
MALE
No
Sponsors
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Shenzhen People's Hospital
OTHER
Responsible Party
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Locations
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Shenzhen People's Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LL-KY-2024218-04
Identifier Type: -
Identifier Source: org_study_id
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