The First Affiliated Hospital of Xinxiang Medical College
Phase
Observational
Started
2026-03-08
Last updated
2026-06-15
Condition(s) studied
Androgenetic Alopecia (AGA)
Investigational drug(s) / intervention(s)
Collection of ~2 × 12 mm scalp tissueSingle-cell sequencing and spatial transcriptome sequencing
Collection of ~2 × 12 mm scalp tissue: In the AGA group, scalp tissue samples were concurrently harvested from the affected balding area (vertex, Hamilton-Norwood III vertex) and an unaffected non-balding area (the central occipital region along the interauricular line). In healthy controls, scalp tissue was harvested solely from the occipital region.
Single-cell sequencing and spatial transcriptome sequencing: Spatial Transcriptomics Sequencing Samples were embedded in OCT, cryosectioned (10 μm), fixed with methanol, and subjected to H\&E staining. After permeabilization (14 min) and RNA capture, libraries were constructed and sequenced on the Xenium platform (sequencing depth ≥ 5 million reads per sample).
Single-Cell Sequencing Samples were minced and enzymatically digested using Collagenase IV, Dispase II, and DNAse I, followed by erythrocyte lysis, filtering, and resuspension. Single-cell suspensions were prepared with a cell viability ≥ 90% and a clump rate \< 5%. Sequencing was performed on the 10x Genomics platform (sequencing depth ≥ 10,000 reads per cell).
Study summary
This study utilizes a multi-omics approach to systematically characterize the cellular heterogeneity and spatial architecture of the hair follicle microenvironment in patients with androgenetic alopecia (AGA). Our primary aim is to elucidate the key mechanisms driving hair follicle stem cell (HFSC) exhaustion and to identify potential therapeutic targets. Investigators will collect six groups of scalp tissue samples, which include healthy controls and AGA patients (stratified into younger and older cohorts). By integrating spatial transcriptomics, single - cell sequencing data, investigators will map aberrant cell subpopulations and their complex interaction networks. Furthermore, the identified core targets will be functionally validated using patient-derived organoids and animal models. Expected outcomes include the identification of 3-5 critical cell subpopulations and the discovery of 8-10 disease-associated targets. Additionally, investigators will establish an integrated clinical-omics-validation database, providing a robust theoretical foundation for the precision diagnosis and treatment of AGA.
Eligibility
Sex
MALE
Min age
20 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Age and Gender: Males aged 25-30 or 60-65 years.
* Diagnosis: Patient Group: Diagnosed by a physician with Hamilton-Norwood Stage III androgenetic alopecia (AGA). Healthy Control Group: Healthy scalp with no signs of hair loss.
* Medication and Treatment History: No use of anti-hair loss medications (e.g., minoxidil, finasteride), hormonal drugs, or scalp chemical treatments (perm or dye) within the last 6 months.
* Informed Consent: Voluntarily signed and provided written informed consent.
Exclusion Criteria:
* Scalp Conditions: Presence of other types of alopecia (besides AGA) or active scalp diseases (e.g., psoriasis, dermatitis, infections).
* Medical History: History of keloids or coagulation disorders.
* Systemic Diseases: Major underlying conditions, including severe cardiovascular/cerebrovascular diseases, immune system disorders, or malignant tumors.
* Allergies: Known hypersensitivity to local anesthetics.
* Prior Clinical Trials: Participation in any other clinical trials within 3 months prior to screening.
* Other Factors: Any other conditions deemed unsuitable for participation by the investigator.
Primary outcome measure(s)
Number of participants with type III vertex androgenetic aopecia (AGA) as assessed by the Hamilton-Norwood classification — at enrollment Visually evaluated according to the Hamilton-Norwood classification, the presentation is consistent with Type III Vertex, manifesting as pronounced hair thinning or circumscribed alopecia at the vertex, alongside frontotemporal recession that does not surpass a standard Type III
Cell viability percentage and RNA integrity number (RIN) / DV200 scores of scalp tissue samples — 30 days For single-cell RNA sequencing (scRNA-seq) sample quality control (QC), cell suspensions must demonstrate ≥80% viability, \<5% clumping, optimal concentrations of 700-1,200 cells/µL, cell sizes \<40 µm, and a debris-free background. For spatial transcriptomics QC, samples require an RNA Integrity Number (RIN) ≥7.0 for fresh frozen (FF) tissues or DV200 ≥50% for formalin-fixed paraffin-embedded (FFPE) tissues; furthermore, tissue sections (typically 10 µm for FF and 5 µm for FFPE) must be perfectly flat, free of folds, tears, or ice crystal artifacts, and fit strictly within the designated capture area of the chip.
Number of candidate biomarkers identified for the molecular diagnosis of hair loss — About 150 days after all sample collected By integrating spatial transcriptomic and single-cell expression landscapes, investigators aim to construct a comprehensive 'clinical sample-omics data-target validation' relational database, thereby identifying 2-3 candidate biomarkers for the molecular diagnosis of hair loss
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospiatl of Henan Medical University
Xinxiang
Henan
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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