Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-05-31

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.

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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.

Conditions

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Vitiligo

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cell transplantation group

Epidermal Cell transplantation in patients with vitiligo

Group Type EXPERIMENTAL

Melanocyte transplantation

Intervention Type BIOLOGICAL

Injection of melanocytes directly in Epidermis

Interventions

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Melanocyte transplantation

Injection of melanocytes directly in Epidermis

Intervention Type BIOLOGICAL

Other Intervention Names

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cell therapy cell transplantation

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