Umbilical cord stem cell exosomes for hair regrowth in male pattern baldness

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Androgenic Alopecia: A Prospective, Randomized, Controlled Clinical Trial

This study will try lyophilized exosomes from umbilical cord mesenchymal stem cells delivered with automated microneedles to promote hair regrowth in men with early-to-moderate male pattern baldness.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Male
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT07373054 on ClinicalTrials.gov

What this trial studies

This interventional trial tests topical, lyophilized human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) delivered to the scalp using an automated microneedle system for androgenic alopecia. The protocol uses a dual-layer lyophilization process to preserve exosomal bioactivity at room temperature and compares an innovative lyophilized exosome product with a traditional lyophilized powder, alongside comparators such as topical minoxidil and electric microneedling. Automated microneedling is used to ensure uniform penetration and controlled depth for consistent transdermal delivery. Study endpoints focus on safety and objective measures of hair growth over the treatment period.

Who should consider this trial

Good fit: Ideal candidates are generally healthy men aged 18–60 with clinically diagnosed androgenetic alopecia (Hamilton-Norwood stage II–IV) of less than five years' duration who can attend the Fuzhou study site and refrain from other alopecia treatments during the trial.

Not a fit: Patients with advanced or scarring hair loss, recent malignancy, significant hypotension, women, or those unwilling to stop other alopecia treatments are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve hair regrowth with a favorable safety profile and easier room-temperature storage compared with cell-based therapies.

How similar studies have performed: Small pilot studies and preclinical work on stem-cell-derived exosomes and microneedle delivery have shown promising signs of hair regrowth, but large randomized trials are limited and the approach remains relatively novel.

Eligibility criteria

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.

Where this trial is running

Fuzhou, Fujian

• Affiliated Union Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: xiaosong chen

Conditions Androgenic Alopecia; stem cell; exosome