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.
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.
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).
Parallel
Topical Minoxidil
DrugFollowing 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 Microneedling
Procedure/SurgeryPerformed 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 Powder
Biological/VaccineA solution of exosomes (3 mL) prepared using the traditional purification process, for topical application after microneedling.
Innovative Exosome Lyophilized Powder
Biological/VaccineA solution of exosomes (3 mL) prepared using a novel purification process with an inner-outer bilayer membrane lyoprotection system, for topical application after microneedling.
Hair Density in the Alopecia Area
Trichoscopic hair count (hairs/cm²) in a fixed 1 cm² frontal/vertex scalp area.
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).
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%).
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).
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.
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%.
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.
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。
Click on the lead sponsor to view all of their trials.
