Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.

Detailed Description
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Vitiligo is a pigmentation disorder in which white patches of skin appear on different parts of the body. Histologically it is characterized by absence of melanocytes along the epidermal basal layer. Using cell suspension with non-cultured melanocytes which injected into blister of depigmented lesion, a success rate of 85% was reported for repigmentation. However there are some limitations in this technique: the induction of blister is limited to several sites of the body, hypo-pigmentation around the recipient area due to cryodamage of peripheral melanocytes and leakage of suspension out of the blister. To reduce these problems, in this study we will inject melanocytes directly to epidermis. A shaved biopsy specimen (about 1 cm2) is taken from the patient's normally pigmented area under local anesthesia (lidocaine hydrochloride 20 mg/ml). The specimens are incubated in 0.25% trypsin solution for 15 minutes at 37°C 0.02% EDTA solution for 10 minutes. Then epidermal sheets are gently manipulated with forceps to dissociate the epidermal cells and to yield a cell suspension, followed by treatment with 0.5% trypsin/versene solution at 37C for 3-5 minutes. Well-dispersed cell suspension is aspirated into 1 ml syringes and injected directly in epidermis.

Official Title
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Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Conditions
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Vitiligo

Intervention / Treatment
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* Biological: Melanocyte transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 12 years Stable form of vitiligo (no increase in the size of the lesion for at least one year) No use of immunosuppressive & cytotoxic drugs at least for past 6 months Exclusion Criteria: Pregnant patients Patients with active disease Infection at the recipient site Evidence of köebner in the past Keloidal tendencies

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cell transplantation group<br>Epidermal Cell transplantation in patients with vitiligo | Biological: Melanocyte transplantation<br>* Injection of melanocytes directly in Epidermis<br>* Other names: cell transplantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of repigmentation |  | 2 and 4 weeks after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stability of the achieved repigmentation |  | 6 months after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanocytes