Could stem cell 'messages' regrow hair? new trial begins.
NCT ID NCT07373054
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study tests whether tiny particles from stem cells (exosomes) can safely help regrow hair in men with androgenic alopecia (male pattern baldness). The exosomes are delivered into the scalp using a microneedle device. The trial will enroll 18 men aged 18 to 60 with mild to moderate hair loss. Researchers will measure changes in hair density, thickness, and overall appearance over the study period.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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18 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Aug 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001, China
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Other studies related to the condition(s) this trial covers.
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