Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

Study Overview
=================
Brief Summary
-----------------
Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating larger areas with better cosmetic results as compared to other grafting methods. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is an autologous cell harvesting device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. Furthermore, the ReCell device needs no laboratory facilities. Therefore, it is promising for patients with large vitiligo and piebaldism lesions. Objectives: Primary: to asses the efficacy and safety of autologous epidermal cell suspension grafting with the ReCell device after CO2 laser abrasion compared to CO2 laser abrasion alone and no treatment, in patients with piebaldism and stable vitiligo. Secondary: to assess the practical aspects and patients satisfaction of autologous epidermal cell suspension grafting with the ReCell device. Study design: Prospective observer blinded randomized controlled pilot study. Study population: 10 patients ≥ 18 years with stable segmental vitiligo or piebaldism who are under treatment at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical Centre University of Amsterdam. Methods: Three depigmented regions on the trunk or proximal extremities will be randomly allocated to; CO2 laser abrasion + ReCell autologous cell suspension grafting, or CO2 laser abrasion, or no treatment. After the transplantation, UV-treatment according to the standard treatment protocol of the NIPD will be started on all sites and continued for 3 months. Three and six months after grafting, the percentage of repigmentation of the lesions will be assessed.

Official Title
-----------------
Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Pilot Study

Conditions
-----------------
Piebaldism, Segmental Vitiligo

Intervention / Treatment
-----------------
* Procedure: ReCell epidermal cell suspension grafting
* Procedure: CO2 laser abrasion + UV-therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with piebaldism Patients with segmental vitiligo,stable since 12 months without systemic therapy or topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions with at least three depigmented skin lesions on the proximal extremities or trunk larger than 3x3 cm or one lesion of at least 9x3 cm Age >18 willing and able to give written informed consent Exclusion Criteria: UV therapy or systemic immunosuppressive treatment during the last 12 months Local treatment of vitiligo during the last 12 months Vitiligo lesions with follicular or non-follicular repigmentation Skin type I Recurrent HSV skin infections Hypertrophic scars Keloid Cardial insufficiency Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anesthesia. Patients who are pregnant or breast-feeding Patients not competent to understand the procedures involved Patients with atypical nevi Patients with a personal history of melanoma or non-melanoma skin cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReCell epidermal cell suspension grafting<br>CO2 laser abrasion + ReCell epidermal cell suspension + UV-therapy | Procedure: ReCell epidermal cell suspension grafting<br>* According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser) after which the prepared ReCell cell suspension will be sprayed on.<br>|
| Active Comparator: CO2 laser abrasion + UV-therapy<br>According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser) | Procedure: CO2 laser abrasion + UV-therapy<br>* According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser)<br>|
| No Intervention: No treatment + UV-therapy<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of repigmentation | Objective assessment of the degree of repigmentation 6 months after autologous epidermal cell suspension grafting. Assessment will be done by standardized photographs and a digital image analysis system. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual assessment of side effects per treatment region | Visual assessment of side effects per treatment region (hyper pigmentation, hypo pigmentation and scar on a scale from 0-3) will be done by a blinded investigator | 6 months | 
| General outcome assessed by the patient | General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent) | 6 months |