Trial | NCT00631865  Report issue

Official Title

Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    melanocytes ...

  • Study Participants

    300
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.
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 Started
Feb 28
2009
Primary Completion
Feb 28
2015
Study Completion
May 31
2015
Last Update
Jul 20
2016
Estimate

Biological Melanocyte transplantation

Injection of melanocytes directly in Epidermis

  • Other names: cell therapy, cell transplantation

cell transplantation group Experimental

Epidermal Cell transplantation in patients with vitiligo

Criteria 

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
No Results Posted