Androgenetic Alopecia (AGA)Phase 2NCT07693244
Exosome Therapy for Male Androgenetic Alopecia
A Phase 2 study testing Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes and Normal Saline (0.9% NaCl) in people with Androgenetic Alopecia (AGA), run by Zhang Han at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if local scalp injection of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) can treat androgenetic alopecia (AGA) in male patients with AGA. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Androgenetic Alopecia (AGA)
- What is being tested?
- Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 10 Nov 2026
- Phase
- Phase 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for enrollment:
- Male subjects aged 18 to 55 years;
- Diagnosis of androgenetic alopecia classified as Norwood-Hamilton grade III-V;
- Stable pattern of hair loss for at least 6 months prior to screening;
- Willingness to refrain from using any other hair loss treatments during the study period and for 6 months after completion of treatment.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Other types of alopecia, including alopecia areata, cicatricial alopecia, or telogen effluvium;
- Use of minoxidil, finasteride, spironolactone, or other hair growth-related medications within 1 year prior to screening;
- Receipt of platelet-rich plasma (PRP), laser cap therapy, or other scalp procedures within 6 months prior to screening;
- History of autoimmune disease, active scalp infection, coagulation disorders, or malignancy;
- Known hypersensitivity to the investigational product or any of its components;
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- Inability to comply with study procedures, incomplete clinical data, or conditions that may interfere with efficacy evaluation;
- Participation in another clinical trial within the study period;
- Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
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
No.28 Fuxing Road
Beijing
han Zhang, 18510009269, zhang_han_0112@163.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Male Androgenetic Alopecia
The goal of this clinical trial is to learn if local scalp injection of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) can treat androgenetic alopecia (AGA) in male patients with AGA.
The main question it aims to answer is:
Read more
Does hUCMSC-Exos injection improve hair regrowth compared with placebo?
Researchers will compare hUCMSC-Exos injection to placebo injection to see if hUCMSC-Exos leads to superior efficacy in hair follicle regeneration, as measured by changes in hair density, hair thickness, and patient-reported outcomes.
Participants will:
Receive randomized, double-blinded local scalp injections of either hUCMSC-Exos or placebo
Attend scheduled follow-up visits for hair assessment and safety monitoring
Undergo photography, trichoscopy, and complete quality-of-life or psychosocial burden questionnaires as applicable
Read the detailed description
Androgenetic alopecia (AGA) is a chronic, progressive condition characterized by gradual miniaturization of hair follicles in a patterned distribution, primarily influenced by genetic susceptibility and androgen-mediated signaling pathways. The condition involves disruption of the hair cycle, particularly shortening of the anagen phase and progressive conversion of terminal hair follicles into vellus-like follicles, ultimately resulting in visible hair thinning and reduced hair density. In addition to its dermatological manifestations, AGA is associated with significant psychological burden, including decreased self-confidence and impaired quality of life.
Current pharmacological interventions mainly aim to slow disease progression rather than fully restore follicular function. However, their limited efficacy and dependency on continuous administration highlight the unmet need for regenerative and disease-modifying therapeutic strategies.
Mesenchymal stem cell-derived exosomes (MSC-Exos) represent a novel class of cell-free biologics with regenerative and immunomodulatory properties. These nano-sized extracellular vesicles contain bioactive molecules such as proteins, lipids, and nucleic acids, which mediate intercellular communication and regulate multiple biological processes. Among different MSC sources, human umbilical cord-derived MSCs are considered to possess advantageous biological characteristics, including higher proliferative capacity, lower immunogenicity, and more stable paracrine activity, making their exosomes particularly suitable for clinical translation.
Experimental studies have demonstrated that MSC-Exos may influence hair follicle biology through multiple complementary mechanisms, including modulation of dermal papilla cell activity, regulation of signaling pathways involved in follicular cycling, enhancement of vascular support within the perifollicular environment, and attenuation of local inflammatory responses. These combined effects may contribute to the reactivation of dormant follicles and support the transition of hair follicles into the anagen growth phase.
This clinical investigation is designed to translate these preclinical findings into a controlled human study setting, aiming to systematically evaluate the therapeutic potential of hUCMSC-derived exosomes for hair regeneration. The study will generate evidence regarding both clinical efficacy and safety profile, providing foundational data for future development of exosome-based regenerative therapies in androgenetic alopecia.
- Conditions
- Androgenetic Alopecia (AGA)
- Being tested
- Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes, Normal Saline (0.9% NaCl)
- Keywords
- Androgenetic Alopecia, Exosomes, hUCMSC-Exos, Mesenchymal Stem Cells, Randomized Controlled Trial
- 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-Derived ExosomesDrug
Sterile exosome suspension derived from human umbilical cord mesenchymal stem cells (hUCMSC-Exos). Administered via intradermal scalp injection at 0.05 mL per point, 1 cm spacing, approximately 4 mm depth. Treatment repeated once every 4 weeks for a total of 3 sessions.
Normal Saline (0.9% NaCl)Other
Sterile 0.9% normal saline injection. Administered via intradermal scalp injection using the same protocol as the experimental group: 0.05 mL per point, 1 cm spacing, approximately 4 mm depth, once every 4 weeks for a total of 3 sessions.
| Study group | Role | What they receive |
|---|---|---|
| hUCMSC-Exosome Injection | Experimental | Not described Receives: Drug: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes |
| Normal Saline Injection | Placebo comparator | Not described Receives: Other: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hair Density From Baseline to Week 24
Hair density (hairs/cm²) within a predefined target scalp area will be assessed using digital trichoscopy.
Measured: Baseline to Week 24
Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 24
Global scalp photographs will be evaluated by blinded investigators using the Modified Global Photographic Assessment (MGPA) scale to assess overall improvement in hair growth.
Measured: Baseline to Week 24
Secondary outcomes (7)
Change in Hair Density From Baseline to Week 12
Hair density changes within the predefined target area measured by digital trichoscopy.
Measured: Baseline to Week 12
Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 12
Assessment of global hair growth improvement using standardized photography and MGPA scoring.
Measured: Baseline to Week 12
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 24
Evaluation of treatment-related quality of life improvement using the Dermatology Life Quality Index questionnaire.
Measured: Baseline to Week 24
Change in Mean Hair Shaft Diameter From Baseline to Week 24
Mean hair shaft diameter will be measured using digital trichoscopic analysis.
Measured: Baseline to Week 24
Change in Hair Type Proportions From Baseline to Week 24
Percentage changes in vellus hairs, intermediate hairs, and terminal hairs within the target scalp area.
Measured: Baseline to Week 24
Subject Satisfaction Score at Week 24
Participant-reported satisfaction regarding overall hair growth improvement and treatment outcomes.
Measured: Week 24
Investigator Satisfaction Assessment at Week 24
Overall investigator-rated assessment of treatment response and cosmetic improvement.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start30 Apr 2026
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic Alopecia (AGA)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Han, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693244
- Sponsor's protocol ID
- PLAGH-2026-AGA-EXO-001
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing has not yet been determined. Data sharing policies will be considered after study completion in accordance with institutional regulations, ethical requirements, and participant privacy protection.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Male Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07693244
- Acronym / sponsor ID
- PLAGH-2026-AGA-EXO-001
- Conditions
- Androgenetic Alopecia (AGA)
- Keywords
- Androgenetic Alopecia, Exosomes, hUCMSC-Exos, Mesenchymal Stem Cells, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhang HanUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 9 Jul 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.
The goal of this clinical trial is to learn if local scalp injection of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) can treat androgenetic alopecia (AGA) in male patients with AGA.
The main question it aims to answer is:
Does hUCMSC-Exos injection improve hair regrowth compared with placebo?
Researchers will compare hUCMSC-Exos injection to placebo injection to see if hUCMSC-Exos leads to superior efficacy in hair follicle regeneration, as measured by changes in hair density, hair thickness, and patient-reported outcomes.
Participants will:
Receive randomized, double-blinded local scalp injections of either hUCMSC-Exos or placebo
Attend scheduled follow-up visits for hair assessment and safety monitoring
Undergo photography, trichoscopy, and complete quality-of-life or psychosocial burden questionnaires as applicable
Detailed description
Androgenetic alopecia (AGA) is a chronic, progressive condition characterized by gradual miniaturization of hair follicles in a patterned distribution, primarily influenced by genetic susceptibility and androgen-mediated signaling pathways. The condition involves disruption of the hair cycle, particularly shortening of the anagen phase and progressive conversion of terminal hair follicles into vellus-like follicles, ultimately resulting in visible hair thinning and reduced hair density. In addition to its dermatological manifestations, AGA is associated with significant psychological burden, including decreased self-confidence and impaired quality of life.
Current pharmacological interventions mainly aim to slow disease progression rather than fully restore follicular function. However, their limited efficacy and dependency on continuous administration highlight the unmet need for regenerative and disease-modifying therapeutic strategies.
Mesenchymal stem cell-derived exosomes (MSC-Exos) represent a novel class of cell-free biologics with regenerative and immunomodulatory properties. These nano-sized extracellular vesicles contain bioactive molecules such as proteins, lipids, and nucleic acids, which mediate intercellular communication and regulate multiple biological processes. Among different MSC sources, human umbilical cord-derived MSCs are considered to possess advantageous biological characteristics, including higher proliferative capacity, lower immunogenicity, and more stable paracrine activity, making their exosomes particularly suitable for clinical translation.
Experimental studies have demonstrated that MSC-Exos may influence hair follicle biology through multiple complementary mechanisms, including modulation of dermal papilla cell activity, regulation of signaling pathways involved in follicular cycling, enhancement of vascular support within the perifollicular environment, and attenuation of local inflammatory responses. These combined effects may contribute to the reactivation of dormant follicles and support the transition of hair follicles into the anagen growth phase.
This clinical investigation is designed to translate these preclinical findings into a controlled human study setting, aiming to systematically evaluate the therapeutic potential of hUCMSC-derived exosomes for hair regeneration. The study will generate evidence regarding both clinical efficacy and safety profile, providing foundational data for future development of exosome-based regenerative therapies in androgenetic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hUCMSC-Exosome Injection | Experimental | Drug: Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes |
| Normal Saline Injection | Placebo comparator | Other: Normal Saline (0.9% NaCl) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects aged 18 to 55 years;
- Diagnosis of androgenetic alopecia classified as Norwood-Hamilton grade III-V;
- Stable pattern of hair loss for at least 6 months prior to screening;
- Willingness to refrain from using any other hair loss treatments during the study period and for 6 months after completion of treatment.
Key exclusion criteria (9 listed)
- Other types of alopecia, including alopecia areata, cicatricial alopecia, or telogen effluvium;
- Use of minoxidil, finasteride, spironolactone, or other hair growth-related medications within 1 year prior to screening;
- Receipt of platelet-rich plasma (PRP), laser cap therapy, or other scalp procedures within 6 months prior to screening;
- History of autoimmune disease, active scalp infection, coagulation disorders, or malignancy;
- Known hypersensitivity to the investigational product or any of its components;
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-Derived ExosomesSterile exosome suspension derived from human umbilical cord mesenchymal stem cells (hUCMSC-Exos). Administered via intradermal scalp injection at 0.05 mL per point, 1 cm spacing, approximately 4 mm depth. Treatment repeated once every 4 weeks for a total of 3 sessions. | Drug | hUCMSC-Exosome Injection |
| Normal Saline (0.9% NaCl)Sterile 0.9% normal saline injection. Administered via intradermal scalp injection using the same protocol as the experimental group: 0.05 mL per point, 1 cm spacing, approximately 4 mm depth, once every 4 weeks for a total of 3 sessions. | Other | Normal Saline Injection |
Primary outcome
Change in Hair Density From Baseline to Week 24
Time frame: Baseline to Week 24
Hair density (hairs/cm²) within a predefined target scalp area will be assessed using digital trichoscopy.
Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 24
Time frame: Baseline to Week 24
Global scalp photographs will be evaluated by blinded investigators using the Modified Global Photographic Assessment (MGPA) scale to assess overall improvement in hair growth.
7 secondary outcomes
Change in Hair Density From Baseline to Week 12
Time frame: Baseline to Week 12
Change in Modified Global Photographic Assessment (MGPA) Score From Baseline to Week 12
Time frame: Baseline to Week 12
Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 24
Time frame: Baseline to Week 24
Change in Mean Hair Shaft Diameter From Baseline to Week 24
Time frame: Baseline to Week 24
Change in Hair Type Proportions From Baseline to Week 24
Time frame: Baseline to Week 24
Subject Satisfaction Score at Week 24
Time frame: Week 24
Investigator Satisfaction Assessment at Week 24
Time frame: Week 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 9 Jul 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing has not yet been determined. Data sharing policies will be considered after study completion in accordance with institutional regulations, ethical requirements, and participant privacy protection.
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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 2 study testing Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes and Normal Saline (0.9% NaCl) in people with Androgenetic Alopecia (AGA), run by Zhang Han 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 5 inclusion and 9 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 9 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 Han Zhang (18510009269, zhang_han_0112@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hair Density From Baseline to Week 24 (time frame: Baseline to Week 24). The study lists 2 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 9 Jul 2026.