NCT01640678

Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Piebaldism
• Segmental Vitiligo

Interventions

Type	Name	Description
PROCEDURE	ReCell epidermal cell suspension grafting	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.
PROCEDURE	CO2 laser abrasion + UV-therapy	According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser)

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2012-07-16
• Last updated: 2013-08-05

Locations

1 site across 1 country: Netherlands