Epidermal Cell Transplantation in Vitiligo Skin (VITICELL)

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

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.

Study Overview

• Status: Completed
• Conditions: VITILIGO
• Intervention / Treatment: Procedure: Grafting with epidermal cells; Radiation: UVB treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Centre Hospitalier Universitaire de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: Grafting of autologous epidermal harvested cells and UVB; 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.	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.
Active Comparator: UVB treatment; UVB treatment twice a week during 3months	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repigmentation rate at 12 months	Repigmentation rate at 12 months	12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repigmentation > 70% at 12 months	Repigmentation > 70% at 12 months	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: philippe bahadoran, doctor, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): May 30, 2013
• Last Update Submitted That Met QC Criteria: May 29, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: 2010-018886-52

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No