Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Phase 3

Completed

• Conditions: Vitiligo
• Interventions: Biological: Melanocyte transplantation

• Registration Number: NCT00631865
• Lead Sponsor: Royan Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-10
• Status Verified: 2009-02
• Study Start: 2009-02
• Primary Completion: 2015-02
• Study Completion: 2015-05
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cell transplantation group	Melanocyte transplantation	Epidermal Cell transplantation in patients with vitiligo

Primary Outcome Measures

Name	Time	Method
percentage of repigmentation	2 and 4 weeks after transplantation

Secondary Outcome Measures

Name	Time	Method
stability of the achieved repigmentation	6 months after transplantation

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of