Adipose-derived Stem Cells Combined With Excimer Light in the Treatment of Stable Vitiligo

This study aimed to assess the efficacy and safety of intradermal injection of adipose-derived stem cells, alone and combined with excimer light in treatment of stable vitiligo.

Study Overview

• Status: Completed
• Conditions: Stable Vitiligo; Adipose-derived Stem Cells; Excimer Light
• Intervention / Treatment: Procedure: Adipose-derived Stem Cells Combined With Excimer Light

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Adipose-derived Stem Cells Combined With Excimer Light; All patients received adipose-derived stem cells combined with excimer light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitiligo Disease Activity (VIDA) Score	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: 4: Active disease (new lesions or expansion) within the last 6 weeks.; 3: Active disease between 6 weeks and 3 months.; 2: Active disease between 3 and 6 months.; 1: Active disease between 6 and 12 months. 0: Stable disease with no changes for 1 year or longer.1: Stable for 1 year or longer, showing signs of spontaneous repigmentation	6 months post-procedure

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 36264MD92/5/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No