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
RenovaCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK)
(previous name: ReCell) is a device which, compared to other forms of autologous epidermal
cell suspension grafting, is easier in use showing similar results. Efficacy and safety of
the ReCell device was proven in segmental vitiligo and piebaldism. However, the efficacy in
non-segmental vitiligo is not yet confirmed in randomized controlled trials. The
investigators hypothesize that grafting using the ReNovaCell device in combination with
standard of care is also effective in stable non-segmental vitiligo and more effective than
standard of care alone.
Primary: to assess the efficacy and safety of ReNovaCell grafting combined with 311 nm UVB
therapy and topical anti-inflammatory therapy for the treatment of stable non-segmental
vitiligo. Secondary: to assess, satisfaction, cosmetic acceptability, noticeability and
persistence of repigmentation after ReNovaCell transplantation.
Study design: Prospective, observer-blinded, randomised, within subject, controlled, study.
Study population: 20 patients ≥ 18 years with stable non-segmental vitiligo receiving
standard of care (311 nm UVB therapy and topical anti-inflammatory therapy) for at least 6
months at the Netherlands Institute for Pigment Disorders (NIPD) at the Academic Medical
Centre, University of Amsterdam.
Intervention: In patients already receiving standard of care (311 nm UVB therapy + topical
anti-inflammatory therapy) 2 comparable depigmented regions are randomised to receive
ReNovaCell grafting or no grafting. Standard of care will be given according to the standard
treatment protocol of our institute.
Main study parameters/endpoints:
Objective assessment of the degree of repigmentation three and six months after ReNovaCell
grafting with a digital image analysis system. To assess the pigmentation, the contours of
pigmentation are copied on a transparent sheet before, three and six months after treatment,
after which the sheets are scanned and digital image analysis is used to compute the affected
surface. By comparing pre- and post-treatment pictures, the relative surface showing
repigmentation expressed as percentage of the selected treated patch is computed.
- Patient Reported Outcomes: satisfaction, cosmetic acceptability, noticeability
- General patient assessed outcome per treatment region on a scale from 0-3 (poor,
moderate, good or excellent).
- Visual assessment of percentage repigmentation by blinded observer and color match to
- Visual assessment of side effects per treatment region (hyperpigmentation,
hypopigmentation and scarring on a scale from 0-3) by a blinded investigator.
- A small amount of the suspension of the included patients and the redundant lesional
punchgrafts of all patients will be used for flow cytometric analyses of the cellular
composition of the grafted cell suspension, and expression analysis of melanin
synthesis-related genes. These data will be correlated to the clinical data.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: As the study involves large depigmented lesions, which are too large to treat in
regular surgical treatment (punch grafting), patients will not miss any regular treatment.
The time investment for the patient will be approximately 20 minutes for the punchgrafting
session, 75 minutes for the cell suspension grafting session and 15 minutes for the three
follow-up visits. Two of the five visits are part of the standard of care UVB follow-up
regimen and are therefore not additional due to the study. Infection in the grafted area or
the donor site may occur but is very rare; the risk of mild textural changes in the donor
site is moderate. Hyperpigmentation of the treated area does occur often, although this
improves over time in most cases. In case of improvement of the depigmentation, patients may
receive another treatment for the (contralateral) untreated side.