Autologous cell suspension grafting using ReCell in vitiligo and piebaldism patients: a randomized controlled study on the recipient site preparation

Piebaldism and vitiligo are skin conditions characterized by depigmented
macules, which are congenital or occur in the course of life, respectively. The
lesions are often regarded disturbing by patients and patients may suffer from
social stigmatization. Cel suspension grafting is a well recognized treatment
option for stable lesions. In epidermal cell suspension grafting, a
split-thickness graft of normally pigmented skin is processed into a cell
suspension, which is subsequently applied on the depigmented macules. Before
grafting, the depigmented macules are pretreated with an ablative laser,
(partially) removing the epidermis. The advantage of this technique is that
relatively large depigmented areas can be treated with relatively little donor
material. Epidermal cell suspension grafting is carried out in routine clinical
practice in specialized centres elsewhere in Europe. In most epidermal cell
suspension grafting techniques, specialized laboratory facilities are required.
To date, these techniques could therefore not be used at the Netherlands
Institute for Pigment Disorders. More recently, the ReCell technique was
developed. In this technique, the cell suspension is prepared using a
prefabricated kit, enabling treatment in an outpatient clinic. An earlier pilot
study conducted at our institute showed that significant repigmentation could
be achieved using this method. However, laser pretreatment has been relatively
aggressive, resulting is slower wound healing, more patient reported complaints
and a higher risk of e.g. scarring. Much is still unknown regarding to laser
pretreatment in cell suspension grafting. Pretreatment with less invasive
settings (lower ablation depth or pretreatment with so called fractional
settings, where an array of microscopic channels is created in the skin,
leaving the surrounding skin intact) may also be effective.

Primary: to assess the efficacy and safety of autologous epidermal cell
suspension grafting using the ReCell kit after CO2 laser abrasion with
superficial full surface ablation, fractional laser treatment and conventional
(deep) full surface CO2 laser ablation.

Secondary: to assess the practical aspects and the general outcome by the
patient, of autologous epidermal cell suspension grafting technique using the
ReCell device after different methods to prepare the recipient site and to
assess the cellular properties of the cell suspension by analysing the density
of melanocytes, keratinocytes, stem cells, viable melanocytes and keratinocytes
in the cell suspension.

Prospective, observer- blinded, randomised, within subject, controlled study.

Four depigmented regions on the trunk or extremities will be randomly allocated
to:

I CO2 ActiveFx 200 mJ 60 W density 3 (full surface ablation, depth 209 µm) +
ReCell epidermal skin graft suspension
II CO2 ActiveFx 150 mJ 60 W density 3 (full surface ablation, depth 150 µm) +
ReCell epidermal skin graft suspension
III CO2 DeepFx 7.5 mJ/ microbeam 20% (fractional ablation, depth 225 µm,
width 120 µm) + ReCell epidermal skin graft suspension
IV untreated control region

After the transplantation, UV-treatment according to the standard treatment
protocol of the Netherlands Institute for Pigment Disorders will be started on
all sites and continued for three months. Six months after grafting, the
percentage of repigmentation of the lesions will be assessed.

As the study involves large depigmented lesions, which are too large to treat
in regular surgical treatment, patients will not miss any regular treatment.
The time investment for the patient will be approximately 75 for the treatment
session (one hour for the actual grafting procedure), two follow-up visits and
15 minutes twice a week at home for the UV- therapy. Infection in the grafted
area or the donor site may occur but is very rare; the risk of scarring 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, the most efficacious treatment modality will be offered to
treat the whole depigmented skin area.