Androgenic AlopeciaPhase 1/2MSCs treatmentNCT07203599
A Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
A Phase 1/2 study testing Human umbilical cord mesenchymal stem cell exosomes and Minoxidil 5% Topical Solution in people with Androgenic Alopecia, run by Shenzhen People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Human umbilical cord mesenchymal stem cell exosomes and Minoxidil 5% Topical Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 1 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Male patients aged 18-35 2. Clinically diagnosed with androgenic alopecia, Hamilton Norwood Scale III-V 3. Patients who voluntarily participate in clinical trials and sign informed consent forms
Who cannot join
- 1. Known alcohol allergy 2. Patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine, or hematopoietic system 3. Patients with other scalp diseases or hair loss diseases 4. Patients with severe mental illness and cognitive impairment 5. Patients with poor nutritional status and low immune function 6. Within 1 year, those who have used systemic corticosteroids, immunosuppressants, cytotoxic drugs, and peripheral vasodilators 7. Within 6 months, those who have used systemic or local drugs to treat hair loss, such as finasteride, minoxidil, etc 8. Within 3 months, those who have received other clinical trial drugs 9. Family genetic history or other criteria considered unsuitable by researchers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Zhenjun Deng, Ph.D, +86 18487380167, deng.zhenjun@szhospital.com
About this study
Official title: A Randomized Controlled Clinical Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
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?
Read more
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
- Androgenic Alopecia
- Being tested
- Human umbilical cord mesenchymal stem cell exosomes, Minoxidil 5% Topical Solution
- Keywords
- androgenic alopecia, human umbilical cord mesenchymal stem cell exosomes
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cell exosomesDrug
Also called hUCMSC-sEV
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 SolutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Drug: Human umbilical cord mesenchymal stem cell exosomes |
| Group B | Experimental | 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. Receives: Drug: Human umbilical cord mesenchymal stem cell exosomes |
| Group C | Experimental | 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. Receives: Drug: Human umbilical cord mesenchymal stem cell exosomes |
| hUCMSC-sEV treatment group | Experimental | Participants will receive one injection site for each 1 cm² of hair loss area with the optimal dose of hUCMSC-sEV. Receives: Drug: Human umbilical cord mesenchymal stem cell exosomes |
| Minoxidil treatment group | Active comparator | Participants will get 1 mL of minoxidil administered daily to the area of hair loss. Receives: Drug: Minoxidil 5% Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair density
Hair density will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Measured: From the first treatment to 24 weeks.
Hair diameter
Hair diameter will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Measured: From the first treatment to 24 weeks.
Hair count
Hair count will be measured by dermoscopy at weeks 0, 8, 12 and 24.
Measured: From the first treatment to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start20 Sep 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203599
- Sponsor's protocol ID
- LL-KY-2024218-04
- Acronym
- MSCs treatment
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study on the Treatment of Androgenetic Alopecia in Young Men With Umbilical Cord Mesenchymal Stem Cell Exosomes
- ClinicalTrials.gov ID
- NCT07203599
- Acronym / sponsor ID
- MSCs treatment / LL-KY-2024218-04
- Conditions
- Androgenic Alopecia
- Keywords
- androgenic alopecia, human umbilical cord mesenchymal stem cell exosomes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Human umbilical cord mesenchymal stem cell exosomesParticipants 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. |
| Group B | Experimental | Drug: Human umbilical cord mesenchymal stem cell exosomesParticipants 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. |
| Group C | Experimental | Drug: Human umbilical cord mesenchymal stem cell exosomesParticipants 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. |
| hUCMSC-sEV treatment group | Experimental | Drug: Human umbilical cord mesenchymal stem cell exosomesParticipants will receive one injection site for each 1 cm² of hair loss area with the optimal dose of hUCMSC-sEV. |
| Minoxidil treatment group | Active comparator | Drug: Minoxidil 5% Topical SolutionParticipants will get 1 mL of minoxidil administered daily to the area of hair loss. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Male patients aged 18-35 2. Clinically diagnosed with androgenic alopecia, Hamilton Norwood Scale III-V 3. Patients who voluntarily participate in clinical trials and sign informed consent forms
Key exclusion criteria (1 listed)
- 1. Known alcohol allergy 2. Patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine, or hematopoietic system 3. Patients with other scalp diseases or hair loss diseases 4. Patients with severe mental illness and cognitive impairment 5. Patients with poor nutritional status and low immune function 6. Within 1 year, those who have used systemic corticosteroids, immunosuppressants, cytotoxic drugs, and peripheral vasodilators 7. Within 6 months, those who have used systemic or local drugs to treat hair loss, such as finasteride, minoxidil, etc 8. Within 3 months, those who have received other clinical trial drugs 9. Family genetic history or other criteria considered unsuitable by researchers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human umbilical cord mesenchymal stem cell exosomesAlso: hUCMSC-sEVHuman 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. | Drug | Group A, Group B, Group C, hUCMSC-sEV treatment group |
| Minoxidil 5% Topical SolutionTopical 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. | Drug | Minoxidil treatment group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human umbilical cord mesenchymal stem cell exosomes and Minoxidil 5% Topical Solution in people with Androgenic Alopecia, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianglin Zhang, Ph.D (+86 13873143466, zhang.jianglin@szhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair density (time frame: From the first treatment to 24 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.