Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Royan Institute

Status and phase: Completed; Phase 3

Conditions: Vitiligo

Treatments: Biological: Melanocyte transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00631865

Royan-skin-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

cell transplantation group

Experimental group

Description:

Epidermal Cell transplantation in patients with vitiligo

Treatment:

Biological: Melanocyte transplantation