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Completed

NCT Number: NCT00631865

Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

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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Key information

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royan Institute

Tehran, Tehran Province, 1665659911, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melanocyte transplantation

Biological

Injection of melanocytes directly in Epidermis

Other names: cell therapy, cell transplantation

Primary outcomes

  1. percentage of repigmentation

    Time frame: 2 and 4 weeks after transplantation

Secondary outcomes

  1. stability of the achieved repigmentation

    Time frame: 6 months after transplantation

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 10, 2008
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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