Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Vitiligo Clinical Trial

Official title:

Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631865
• Other study ID #: Royan-skin-001
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2008
• Last updated: July 18, 2016
• Start date: February 2009
• Est. completion date: May 2015

Study information

• Verified date: February 2009
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Biological:
• Melanocyte transplantation
Injection of melanocytes directly in Epidermis

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of repigmentation		2 and 4 weeks after transplantation	Yes
Secondary	stability of the achieved repigmentation		6 months after transplantation	Yes

External Links

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