Epidermal Cell Transplantation in Vitiligo Skin

VITILIGO Clinical Trial

— VITICELL  

Official title:

Efficacy and Tolerance of Transplantation of Harvested Epidermal Cells and Narrow-Band UVB in Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629979
• Other study ID #: 2010-018886-52
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 23, 2012
• Last updated: May 29, 2013
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

The effects of treatment of transplantation of harvested autologous epidermal cells on vitiligo lesions followed by narrow-band UVB will be investigated in a randomized controlled study.

Description:

Introduction: Transplantation of harvested autologous epidermal cells in vitiligo is widely used in vitiligo but randomized controlled trials in the literature investigating the efficacy of these noncultured keratinocyte/melanocyte suspensions are scarce. In addition there are few data regarding the relationship between the cellular contents of epidermal suspensions and the clinical outcome.

Aim of the study: To perform a prospective, controlled, randomized, intra-individual comparative study in vitiligo lesions treated with epidermal cell transplantation with additional narrow-band UVB treatment using epidermal cell suspensions that have been characterized at the cellular level.

Study design:

Grafting with epidermal cells: A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated.

Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

Evaluation of the treatment success: The grade of pigmentation in all lesions will be evaluated clinically, with photographs. The clinical rating will be performed as follows: 0 = no repigmentation; 1 = 1-25% repigmentation; 2 = 26 to 50% repigmentation; 3 = 51 to 75% repigmentation; and 4 = 76 to 100% repigmentation. The evaluation of the photographs will be performed blinded by physicians not engaged in the treatment phase of the study. In addition the surface of vitiligo patches will be traced on transparent sheets and monitored by planimetry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age > 18yr

• Stable vitiligo (no lesion since 12 mo)

• 2 symmetrical vitiligo patches of at least 10 cm2

• Vitiligo requiring UVB treatment

• Women using a contraceptive

Exclusion Criteria:

• History of keloids

• History of skin cancer

• Photosensitivity

• Positive blood test for HIV, HBV, HVC, or HTLV1

• Pregnant or breastfeeding women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• VITILIGO

Intervention

Procedure:
• Grafting with epidermal cells
A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated. Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

Radiation:
• UVB treatment
the control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.

Locations

Country	Name	City	State
France	Centre hospitalier Universitaire de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repigmentation rate at 12 months	Repigmentation rate at 12 months	12months	No
Secondary	Repigmentation > 70% at 12 months	Repigmentation > 70% at 12 months	12 months	No