Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Segmental VitiligoPiebaldism
Interventions
DEVICE

ReCell

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.

DEVICE

Full surface CO2 laser 200 mJ

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

DEVICE

Full surface CO2 laser 150 mJ

Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3

DEVICE

Fractional CO2 laser 7.5 mJ, 20%

Pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density.

Trial Locations (1)

1105 AZ

Netherlands Institute for Pigment disorders, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Avita Medical

INDUSTRY

lead

Netherlands Institute for Pigment Disorders

OTHER

NCT02458417 - Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients | Biotech Hunter | Biotech Hunter