Androgenic AlopeciaNCT07373054
Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia
A study testing Topical Minoxidil, Electric Microneedling and Traditional Exosome Lyophilized Powder in people with Androgenic Alopecia, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Androgenic Alopecia(AGA) is a highly prevalent condition for which existing pharmacological and surgical interventions present limitations and side effects, creating a clinical need for safer and more effective therapies. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Topical Minoxidil, Electric Microneedling and Traditional Exosome Lyophilized Powder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male, aged 18 to 60 years (inclusive), in good general health.
- Clinical diagnosis of androgenetic alopecia (AGA) according to the 2023 Chinese Clinical Practice Guideline: Diagnosis and Treatment of Androgenetic Alopecia, with a disease duration of less than 5 years and a Hamilton-Norwood scale classification of stage II to IV at the screening visit.
- Able to fully understand the study's content, procedures, potential benefits, and risks, and willing to provide written informed consent prior to any study-specific procedures.
- Agrees to comply with the study protocol and refrain from using any other treatments for alopecia for the duration of the study.
Who cannot join
- Unwilling or unable to provide written informed consent.
- History of any malignancy within the past 5 years (except for adequately treated non-scalp basal cell carcinoma or squamous cell carcinoma in situ).
- Hypotension (blood pressure < 90/60 mmHg) documented within 1 month prior to screening, or uncontrolled hypertension within 3 months prior to screening (defined as failure to achieve a target of < 140/90 mmHg while on a stable regimen of at least two antihypertensive medications).
- Known history of any systemic disease that may affect hair growth or confound study assessments (e.g., HIV infection, connective tissue disease, inflammatory bowel disease, hypothyroidism, iron deficiency anemia, malnutrition, syphilis).
- Known history of other forms of non-androgenetic alopecia (e.g., diffuse alopecia, alopecia areata, cicatricial alopecia).
- History of major organ dysfunction, significant autoimmune disease, or immunodeficiency.
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- Known coagulation disorders, current use of anticoagulant or antiplatelet therapy (except low-dose aspirin), thrombophilia, or inherited bleeding disorders.
- Treatment with chemotherapy, cytotoxic drugs, scalp radiation, or laser/surgical hair restoration within 12 months prior to screening.
- History of hair transplantation, or need for long-term use of wigs, hairpieces, or hair bonding agents during the trial.
- History of severe or multiple drug allergies, atopy, known allergy to local anesthetics, or planned desensitization therapy during the study period.
- Presence of any active dermatological condition in the target scalp area that could interfere with evaluation (e.g., infection, seborrheic dermatitis, psoriasis, eczema, folliculitis, open wounds, scars, or atrophy).
- Participation in another interventional clinical trial within 4 weeks prior to screening (except for non-interventional studies or participants who only signed the informed consent form without receiving any investigational product).
- Any other medical or psychiatric condition that, in the judgment of the investigator, would compromise the subject's safety, compliance, or suitability for study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001
About this study
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia: A Prospective, Randomized, Controlled Clinical Trial
Androgenic Alopecia(AGA) is a highly prevalent condition for which existing pharmacological and surgical interventions present limitations and side effects, creating a clinical need for safer and more effective therapies. In response, human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) have emerged as a cell-free therapeutic strategy. Characterized by their rich bioactive components, absence of tumorigenic risk, and high safety profile, hUCMSC-Exos represent a promising approach for hair regeneration. This study aims to evaluate the safety and efficacy of hUCMSC-Exos combined with automated microneedle delivery for treating AGA. By utilizing innovative lyophilization technology to maintain exosomal bioactivity and employing precision microneedle systems for enhanced delivery, this research seeks to provide a new generation solution for androgenic alopecia treatment.
Read the detailed description
Androgenic Alopecia (AGA) is a prevalent hereditary condition with significant limitations in current treatment options. Pharmacological therapies are often associated with gender-specific restrictions and adverse effects including sexual dysfunction and hypertrichosis, while surgical and immunotherapeutic approaches face challenges of high cost, limited efficacy, and potential complications. These shortcomings highlight the urgent clinical need for safer and more effective treatment strategies. Human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos), nano-scale vesicles measuring 30-150 nm in diameter, present a promising alternative. Enriched with bioactive components including proteins and lipids, these cell-free structures demonstrate no proliferative capacity, tumorigenic risk, or significant cytotoxicity, offering a superior safety profile compared to conventional stem cell therapies. This study employs an innovative "dual-layer membrane lyophilization system" that maintains exosomal bioactivity while enabling room temperature storage and transportation through optimized freeze-drying and reconstitution processes.
To address transdermal delivery challenges, the research utilizes an automated microneedle system that overcomes the limitations of traditional injection and roller microneedle methods in achieving uniform penetration and depth control. This advanced delivery platform ensures precise, consistent, and efficient exosomal permeation into scalp tissues.This study aims to evaluate the safety and efficacy of the combined approach of hUCMSC-Exos and automated microneedle delivery for treating AGA. By integrating innovative lyophilization technology with precision delivery, this research seeks to establish a new generation therapeutic solution for androgenic alopecia.
- Conditions
- Androgenic Alopecia
- Being tested
- Topical Minoxidil, Electric Microneedling, Traditional Exosome Lyophilized Powder, Innovative Exosome Lyophilized Powder
- Keywords
- Androgenic Alopecia, stem cell, exosome
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical MinoxidilDrug
Following the standard treatment protocol, subjects were instructed to topically apply 1 mL of 5% minoxidil twice daily until the completion of the 3-month treatment course. Self-recorded usage of minoxidil was documented in a daily log, which was reviewed by the investigators during each treatment visit.
Electric MicroneedlingProcedure or surgery
Performed with a needle length of ~1.2 mm (adjusted to scalp thickness) at 100-200 Hz. The procedure is conducted in sections (e.g., forehead, vertex, temporal regions) until mild pinpoint bleeding (indicating dermal stimulation) is achieved.
Traditional Exosome Lyophilized PowderBiological
A solution of exosomes (3 mL) prepared using the traditional purification process, for topical application after microneedling.
Innovative Exosome Lyophilized PowderBiological
A solution of exosomes (3 mL) prepared using a novel purification process with an inner-outer bilayer membrane lyoprotection system, for topical application after microneedling.
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil Treatment Group | Active comparator | Not described Receives: Drug: Topical Minoxidil |
| Combination Treatment Group (Traditional) | Active comparator | Not described Receives: Procedure: Electric Microneedling; Biological: Traditional Exosome Lyophilized Powder |
| Combination Treatment Group (Innovative) | Experimental | Not described Receives: Procedure: Electric Microneedling; Biological: Innovative Exosome Lyophilized Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Density in the Alopecia Area
Trichoscopic hair count (hairs/cm²) in a fixed 1 cm² frontal/vertex scalp area.
Measured: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Mean Change in Hair Shaft Diameter
The diameter of at least 20 randomly selected terminal hairs in the alopecia area will be measured using trichoscopy with integrated measurement software, and the mean value will be calculated,Unit of measure: micrometer (μm).
Measured: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Vellus-to-Terminal Hair Ratio
Within a standardized alopecia area , vellus hairs (diameter < 30 μm) and terminal hairs (diameter ≥ 30 μm) will be counted separately via trichoscopy,Their ratio will be calculated. This is a dimensionless value reported as a ratio (e.g., 0.5) or a percentage (e.g., vellus hair proportion of 50%).
Measured: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Photographic Hair Density Score
Standardized photographs (90-degree vertex and 45-degree frontal views) are taken under fixed conditions. A trained, blinded rater will assign a score based on a predefined photographic scale that correlates with hair density (e.g., 1=Sparse to 5=Dense).
Measured: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Secondary outcomes (4)
Physician Global Assessment
Hair loss severity was assessed using the Hamilton-Norwood Classification Scale. It classifies male androgenetic alopecia into ordered categorical stages (I through VII) with recognized variant patterns (e.g., types IIA, IIIA, IVA, VIA). The scale's minimum defined stage is Stage I, representing minimal to no frontotemporal recession. The maximum defined stage is Stage VII, characterized by the most advanced presentation of fusion of the frontotemporal and vertex regions of alopecia, with only a narrow, posteriorly situated horseshoe-shaped band of residual parietal and occipital hair. Evaluations were independently performed by two physicians from the department. In cases of significant discrepancy between the two assessors, a third physician was consulted. The final result was derived from the two most concordant assessments.
Measured: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Patient Satisfaction Evaluation
Patient satisfaction was evaluated using a self-reported satisfaction scale. The scale categories were: Very Satisfied (improvement ≥ 75%), Satisfied (improvement 50% to 75%), Neutral (improvement 25% to 49%), and Dissatisfied (improvement ≤ 25%). The satisfaction rate was calculated as follows: (Number of Very Satisfied + Number of Satisfied) / Total number of patients × 100%.
Measured: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Adverse Events Monitoring
Adverse events, including but not limited to erythema, burning, pruritus, dryness, irritation, hyperpigmentation, edema, hypertrophic scarring, skin ulceration, and infection, were monitored.
Measured: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Visual Analog Scale (VAS) for Pain
Pain was assessed using the Visual Analog Scale (VAS). A linear scale marked from 0 to 10 was used, where the "0" end was labeled "No Pain" and the "10" end was labeled "Worst Pain Imaginable." Patients were instructed to mark on the line corresponding to their subjective pain level, allowing for a quantitative assessment of pain intensity. The VAS scoring criteria were as follows:0: No Pain；1-3: Mild Pain；4-6: Moderate Pain；7-9: Severe Pain；10: Worst Pain Imaginable。
Measured: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start6 Nov 2025
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
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.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenXiaosong, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373054
- Sponsor's protocol ID
- 2025KY611
- Status last verified
- Sep 2026
- First submitted
- 30 Dec 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia: A Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07373054
- Acronym / sponsor ID
- 2025KY611
- Conditions
- Androgenic Alopecia
- Keywords
- Androgenic Alopecia, stem cell, exosome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 28 Jan 2026 (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.
Androgenic Alopecia(AGA) is a highly prevalent condition for which existing pharmacological and surgical interventions present limitations and side effects, creating a clinical need for safer and more effective therapies. In response, human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) have emerged as a cell-free therapeutic strategy. Characterized by their rich bioactive components, absence of tumorigenic risk, and high safety profile, hUCMSC-Exos represent a promising approach for hair regeneration. This study aims to evaluate the safety and efficacy of hUCMSC-Exos combined with automated microneedle delivery for treating AGA. By utilizing innovative lyophilization technology to maintain exosomal bioactivity and employing precision microneedle systems for enhanced delivery, this research seeks to provide a new generation solution for androgenic alopecia treatment.
Detailed description
Androgenic Alopecia (AGA) is a prevalent hereditary condition with significant limitations in current treatment options. Pharmacological therapies are often associated with gender-specific restrictions and adverse effects including sexual dysfunction and hypertrichosis, while surgical and immunotherapeutic approaches face challenges of high cost, limited efficacy, and potential complications. These shortcomings highlight the urgent clinical need for safer and more effective treatment strategies. Human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos), nano-scale vesicles measuring 30-150 nm in diameter, present a promising alternative. Enriched with bioactive components including proteins and lipids, these cell-free structures demonstrate no proliferative capacity, tumorigenic risk, or significant cytotoxicity, offering a superior safety profile compared to conventional stem cell therapies. This study employs an innovative "dual-layer membrane lyophilization system" that maintains exosomal bioactivity while enabling room temperature storage and transportation through optimized freeze-drying and reconstitution processes.
To address transdermal delivery challenges, the research utilizes an automated microneedle system that overcomes the limitations of traditional injection and roller microneedle methods in achieving uniform penetration and depth control. This advanced delivery platform ensures precise, consistent, and efficient exosomal permeation into scalp tissues.This study aims to evaluate the safety and efficacy of the combined approach of hUCMSC-Exos and automated microneedle delivery for treating AGA. By integrating innovative lyophilization technology with precision delivery, this research seeks to establish a new generation therapeutic solution for androgenic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Minoxidil Treatment Group | Active comparator | Drug: Topical Minoxidil |
| Combination Treatment Group (Traditional) | Active comparator | Procedure: Electric Microneedling, Biological: Traditional Exosome Lyophilized Powder |
| Combination Treatment Group (Innovative) | Experimental | Procedure: Electric Microneedling, Biological: Innovative Exosome Lyophilized Powder |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male, aged 18 to 60 years (inclusive), in good general health.
- Clinical diagnosis of androgenetic alopecia (AGA) according to the 2023 Chinese Clinical Practice Guideline: Diagnosis and Treatment of Androgenetic Alopecia, with a disease duration of less than 5 years and a Hamilton-Norwood scale classification of stage II to IV at the screening visit.
- Able to fully understand the study's content, procedures, potential benefits, and risks, and willing to provide written informed consent prior to any study-specific procedures.
- Agrees to comply with the study protocol and refrain from using any other treatments for alopecia for the duration of the study.
Key exclusion criteria (13 listed)
- Unwilling or unable to provide written informed consent.
- History of any malignancy within the past 5 years (except for adequately treated non-scalp basal cell carcinoma or squamous cell carcinoma in situ).
- Hypotension (blood pressure < 90/60 mmHg) documented within 1 month prior to screening, or uncontrolled hypertension within 3 months prior to screening (defined as failure to achieve a target of < 140/90 mmHg while on a stable regimen of at least two antihypertensive medications).
- Known history of any systemic disease that may affect hair growth or confound study assessments (e.g., HIV infection, connective tissue disease, inflammatory bowel disease, hypothyroidism, iron deficiency anemia, malnutrition, syphilis).
- Known history of other forms of non-androgenetic alopecia (e.g., diffuse alopecia, alopecia areata, cicatricial alopecia).
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 |
|---|---|---|
| Topical MinoxidilFollowing the standard treatment protocol, subjects were instructed to topically apply 1 mL of 5% minoxidil twice daily until the completion of the 3-month treatment course. Self-recorded usage of minoxidil was documented in a daily log, which was reviewed by the investigators during each treatment visit. | Drug | Minoxidil Treatment Group |
| Electric MicroneedlingPerformed with a needle length of ~1.2 mm (adjusted to scalp thickness) at 100-200 Hz. The procedure is conducted in sections (e.g., forehead, vertex, temporal regions) until mild pinpoint bleeding (indicating dermal stimulation) is achieved. | Procedure or surgery | Combination Treatment Group (Innovative), Combination Treatment Group (Traditional) |
| Traditional Exosome Lyophilized PowderA solution of exosomes (3 mL) prepared using the traditional purification process, for topical application after microneedling. | Biological | Combination Treatment Group (Traditional) |
| Innovative Exosome Lyophilized PowderA solution of exosomes (3 mL) prepared using a novel purification process with an inner-outer bilayer membrane lyoprotection system, for topical application after microneedling. | Biological | Combination Treatment Group (Innovative) |
Primary outcome
Hair Density in the Alopecia Area
Time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Trichoscopic hair count (hairs/cm²) in a fixed 1 cm² frontal/vertex scalp area.
Mean Change in Hair Shaft Diameter
Time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
The diameter of at least 20 randomly selected terminal hairs in the alopecia area will be measured using trichoscopy with integrated measurement software, and the mean value will be calculated,Unit of measure: micrometer (μm).
Vellus-to-Terminal Hair Ratio
Time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Within a standardized alopecia area , vellus hairs (diameter < 30 μm) and terminal hairs (diameter ≥ 30 μm) will be counted separately via trichoscopy,Their ratio will be calculated. This is a dimensionless value reported as a ratio (e.g., 0.5) or a percentage (e.g., vellus hair proportion of 50%).
Photographic Hair Density Score
Time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Standardized photographs (90-degree vertex and 45-degree frontal views) are taken under fixed conditions. A trained, blinded rater will assign a score based on a predefined photographic scale that correlates with hair density (e.g., 1=Sparse to 5=Dense).
4 secondary outcomes
Physician Global Assessment
Time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Patient Satisfaction Evaluation
Time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Adverse Events Monitoring
Time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Visual Analog Scale (VAS) for Pain
Time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Minoxidil, Electric Microneedling and Traditional Exosome Lyophilized Powder in people with Androgenic Alopecia, run by Fujian Medical University Union 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 2 Sep 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Density in the Alopecia Area (time frame: Within one week prior to treatment initiation, and at Weeks 4, 12, and 24 after the first treatment). The study lists 4 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 Sep 2026.