Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

Netherlands Institute for Pigment Disorders10 enrolled

Overview

The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2 laser abrasion with superficial full surface ablation, fractional laser treatment and conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the patient reported outcome and to assess the cellular composition of the graft.

Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. With this device an epidermal cell suspension is created from a split skin graft, usually taken from the hip region. Currently, conventional ablative (full surface de-epidermisation) laser treatment in different laser settings is used as pre-treatment to prepare the acceptor site for transplantation. There is no evidence for the laser settings used and no studies are available on the use of a fractional laser as pre-treatment in autologous cell suspension grafting using ReCell (ReCell grafting). The investigators hypothesize that more superficial conventional ablative laser treatment and fractional ablative laser treatment are as effective as the current pre-treatment, whereas these treatments are less invasive, provide faster healing and prevent side effects like persisting erythema and scars. Furthermore, infiltration anaesthesia is not necessary with these less invasive treatments.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Segmental Vitiligo Piebaldism

Interventions

ReCellDEVICE

A split-thickness skin biopsy will be taken from the hip region of the patient. The skin biopsy that is obtained will be treated in the ReCell kit (Avita Medical Europe Ltd, Cambridge, UK): it will be placed in the heated enzyme solution, containing trypsin, in the device for 15-20 minutes to allow cell disaggregation. After that period, the biopsy will be taken from the enzyme solution and will be dipped in sodium lactate buffer solution. The biopsy will then be scraped to disaggregate the cells from the dermal epidermal junction. The epidermal cells are drawn up in a syringe. The prepared suspension will be dripped on both donor and acceptor site.

Full surface CO2 laser 200 mJDEVICE

Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 144 µm) and density 3

Full surface CO2 laser 150 mJ

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with, segmental vitiligo or piebaldism under medical treatment at the Netherlands Institute for Pigment Disorders * Age ≥18 * Patient is willing and able to give written informed consent * Segmental vitiligo stable since 12 months without systemic therapy or 12 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions. * At least four depigmented lesions on the proximal extremities or trunk larger than 3x3 cm or one depigmented lesion on the proximal extremities or trunk of at least 12x3 cm. 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 repigmentations * Skin type I * Recurrent HSV skin infections * Hypertrophic scars * Keloid * Cardiac insufficiency * Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anaesthesia. * Patients who are pregnant or breast-feeding * Patients not competent to understand what the procedures involves * Patients with a personal history of melanoma or non-melanoma skin cancer * Patients with atypical nevi. * Known allergy to clarithromycin

Locations (1)

Netherlands Institute for Pigment disorders

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Repigmentation

Assessment will be done by sheets and a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before and six months after treatment, after which the sheets are scanned using a predefined resolution. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch are computed.