- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07603544
Multi-Omics Insights Into Androgenetic Alopecia
Multi-Omics Analysis of the Hair Follicle Microenvironment in Androgenetic Alopecia for Mechanistic Study and Target Identification
Przegląd badań
Status
Warunki
Szczegółowy opis
Data from the 2025 White Paper on China's Scalp Health Industry reveals that the hair-loss population in China has exceeded 340 million. Notably, the 20-to-35 age group accounts for nearly 70% of this demographic (a 23% increase compared to 2020). The post-90s and post-00s generations have become the primary consumers of anti-hair loss products, highlighting an increasingly prominent trend of hair loss occurring at a younger age and correlating with specific occupational profiles. Further demographic analysis indicates that finance and internet professionals enduring chronic high stress and late nights, postpartum women experiencing hormonal fluctuations, dieters with nutritional deficiencies, and individuals who frequently dye or perm their hair collectively constitute a massive and diverse market for anti-hair loss solutions. However, among the various types of hair loss, androgenetic alopecia (AGA), primarily driven by genetic factors, accounts for 80% of young outpatient cases. Epidemiological surveys indicate that the prevalence of AGA in China has reached 21.3% in males and 6% in females. The pathogenesis of AGA is highly complex, involving the interplay of multiple factors such as genetic susceptibility, abnormal androgen metabolism, cellular senescence, neuroendocrine dysregulation, and immune microenvironment imbalances; its precise molecular regulatory networks have yet to be fully elucidated.
In recent years, the rapid advancement of single-cell RNA sequencing (scRNA-seq) and spatial transcriptomics has made them cutting-edge tools for characterizing the hair follicle microenvironment and cellular heterogeneity. In the field of hair aging (graying), research has predominantly focused on the single-cell level. For instance, the first human gray hair single-cell atlas constructed by Wu et al. revealed the synergistic exhaustion mechanism of melanocyte stem cells (McSCs) and matrix hair progenitors. Furthermore, the release of noradrenaline by sympathetic nerves under acute stress, or DNA damage-induced McSC "seno-differentiation" and autoimmune responses, have all been proven to be key drivers leading to the depletion of the stem cell pool.
In exploring the mechanisms of hair loss diseases, the research horizon has further expanded from single-cell analysis to "spatial multi-omics." Spatial omics has demonstrated significant advantages, particularly for hair loss types accompanied by immune infiltration. For example, in scarring alopecia (lichen planopilaris, LPP), the combined application of scRNA-seq and spatial transcriptomics precisely mapped the abnormal accumulation of CD8+ T cells and macrophages in the hair follicle bulge region, elucidating the spatial mechanisms by which IFN-γ and oncostatin M (OSM) drive follicular fibrosis. In alopecia areata (AA), spatial omics revealed that the loss of regulatory T cells around hair follicles is the core cause of immune privilege collapse. Regarding AGA, the primary focus of this study, previous researchers have utilized spatial technologies to preliminarily characterize the fibrotic microenvironment in balding areas and, combined with mouse models, explored the molecular mechanisms by which exosomes promote hair follicle regeneration.
In summary, integrating single-cell resolution with spatial positional information to deeply investigate hair loss mechanisms has become a mainstream trend in this field. Building upon this, the present study proposes a combined application of scRNA-seq and spatial transcriptomics to systematically compare the differences in cellular heterogeneity and spatial architecture of the hair follicle microenvironment between healthy individuals and AGA patients. This study aims to pinpoint the key cell subpopulations and their spatial interaction networks driving hair follicle stem cell (HFSC) exhaustion, comprehensively elucidate the core molecular mechanisms leading to HFSC functional decline, and identify potential therapeutic targets. Ultimately, this will provide a solid theoretical foundation and robust data support for the precision diagnosis and targeted intervention of AGA.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Wenjie Ren
- Numer telefonu: 8618937302619
- E-mail: 157121431@qq.com
Lokalizacje studiów
-
-
Henan
-
Xinxiang, Henan, Chiny, 453003
- The First Affiliated Hospiatl of Henan Medical University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Young healthy controls
Subjects included individuals aged 25 to 35 years classified as Hamilton-Norwood Class I, who had no family history of alopecia, no comorbid scalp disorders, and no exposure to anti-alopecia therapies, hormonal treatments, or chemical hair processing within the preceding 6 months.
|
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.
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). |
|
Young patients with AGA
Patients included individuals aged 25 to 35 years with a confirmed diagnosis of Hamilton-Norwood Grade III, who were free of other forms of alopecia or concurrent scalp disorders, and had no exposure to relevant pharmacological treatments or chemical hair processing within the preceding 6 months.
|
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.
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). |
|
Aged healthy controls
Subjects included individuals aged older than 60 years classified as Hamilton-Norwood Class I, who had no family history of alopecia, no concurrent scalp disorders, and no exposure to anti-alopecia therapies, hormonal treatments, or chemical hair processing within the preceding 6 months.
|
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.
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). |
|
Aged patients with AGA
Patients included individuals aged older than 60 years with a confirmed diagnosis of Hamilton-Norwood Grade III, who were free of other forms of alopecia or concurrent scalp disorders, and had no exposure to relevant pharmacological treatments or chemical hair processing within the preceding 6 months.
|
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.
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). |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Diagonse of AGA
Ramy czasowe: 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
|
at enrollment
|
|
Quality control of the scalp tissues from AGA patients
Ramy czasowe: 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.
|
30 days
|
|
Target screening based on single-cell sequencing and spatial transcriptomics data analysis
Ramy czasowe: About 150 days after all sample collected
|
By integrating spatial transcriptomic and single-cell expression landscapes, we 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
|
About 150 days after all sample collected
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- AGA-XXMU-202602
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Łysienie androgenowe (AGA)
-
Erasmus Medical CenterRekrutacyjnyŁysienie plackowate (AA) | Łysienie plackowate (AA) | Łysienie całkowite (AT) | Alopecia Universalis (AU) | Łysienie całkowite/uniwersalne | Łysienie plackowate (i ofiaza)Holandia
-
Rare Trait HopeJeszcze nie rekrutacjaBezpieczeństwo i skuteczność terapii genowej scAAV9/AGA u uczestników z asparagyloglikozynurią (AGU)Aspartyloglukozaminuria | Niedobór aspartyloglukozamidazy (AGA).
-
Veradermics, Inc.RekrutacyjnyŁysienie androgenowe | AGA | Wypadanie włosów | Kobiece łysienie androgenowe | Łysienie androgenowe (AGA)Stany Zjednoczone
-
Société des Produits Nestlé (SPN)ZakończonyMały dla niemowląt w wieku ciążowym (SGA). | Odpowiedni dla niemowląt w wieku ciążowym (AGA).Indie
-
Hayat Abad Medical Complex, PeshawarJeszcze nie rekrutacjaŁysienie plackowate | Łysienie uniwersalne | Łysienie całkowite (AT)
-
Institute of Dermatology, ThailandMEDEZE Cosmeceutical Company LimitedRekrutacyjnyŁysienie androgenowe (AGA)Tajlandia
-
The First Affiliated Hospital of Soochow UniversityZakończony
-
PfizerIn Expanded Access, treating physicians are the SponsorsDo dyspozycji
-
Assiut UniversityJeszcze nie rekrutacjaŁysienie androgenowe | Łysienie androgenowe (AGA)Egipt
-
University of MinnesotaColumbia UniversityRekrutacyjnyŁysienie plackowate | Łysienie totalne | Łysienie uniwersalneStany Zjednoczone
Badania kliniczne na Collection of ~2 × 12 mm scalp tissue
-
University of BaghdadZakończonyPowikłania związane z aparatem ortodontycznymIrak