Piebaldism Clinical Trial
Official title:
Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Pilot Study
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02458417 -
Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients
|
Phase 4 | |
| Recruiting |
NCT01377077 -
Punchgrafting Techniques for Vitiligo
|
Phase 4 | |
| Completed |
NCT02156427 -
Evaluation of Non-cultured Epidermal Cellular Grafting vs Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism
|
Phase 3 |