Adipose-derived Stem Cells Combined With Excimer Light in the Treatment of Stable Vitiligo
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Vitiligo is a common disfiguring autoimmune disease that negatively affects patients' self-esteem and quality of life. Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.
Adipose tissue-derived stem cells have the capacity to secrete a variable cytokines and growth factors, including hepatocyte growth factor (HGF), interleukin-6 (IL-6), macrophage colony-stimulating factor (M-CSF), transforming growth factor-β1 (TGF-β1), tumour necrosis factor (TNF), vascular endothelial growth factor (VEGF), that stimulate angiogenesis, tissue remodeling, and anti-apoptotic processes. Phototherapy has an eminent effect on stoppage of progression and repigmentaion of vitiligo patches. Narrowband ultraviolet B (NB-UVB) and ultraviolet A (UVA), and monochromatic excimer light (MEL) can be used in treatment of vitiligo. The specific 308-nm radiation wavelength is delivered in a targeted form by the xenon-chloride excimer laser and is also available in an incoherent form that is commonly referred to as the excimer lamp.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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El-Gharbia
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Tanta, El-Gharbia, Egypten, 31527
- Tanta University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients with two or more similar patches of stable vitiligo "absence of new patches of depigmentation or enlargement of the pre-existing patches" for 6 months at least.
- Patients who will accept to be enrolled in the study and will sign an informed consent.
Exclusion Criteria:
- Unstable vitiligo for more than 6 months.
- Current bacterial or viral infection in the treatment area.
- Patients with unrealistic expectation.
- Very thin patients "poor donor areas".
- Patients with uncontrolled systemic disease such as diabetes or hypertension.
- Patients with hepatitis B or C virus infection.
- Patients with any other skin disease.
- Patients with bleeding or coagulopathy disorders.
- Pregnancy and lactation.
- Patients who received topical treatment for vitiligo during the last month, or systemic treatment during the past three months before the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Study group
Patients with two or more similar patches of stable vitiligo "absence of new patches of depigmentation or enlargement of the pre-existing patches" for 6 months at least
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All patients received adipose-derived stem cells combined with excimer light.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vitiligo Disease Activity (VIDA) Score
Tidsramme: 6 months post-procedure
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The Vitiligo Disease Activity (VIDA) Score is a 6-point clinical scale used to measure the progression or stability of vitiligo. The scale ranges from -1 to +4, where higher numbers indicate more recent and rapid disease activity:
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6 months post-procedure
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 36264MD92/5/23
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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