Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients
NCT ID: NCT01640678
Last Updated: 2013-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
10 participants
INTERVENTIONAL
2012-06-30
2013-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ReCell epidermal cell suspension grafting
CO2 laser abrasion + ReCell epidermal cell suspension + UV-therapy
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.
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)
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)
No treatment + UV-therapy
No interventions assigned to this group
Interventions
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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.
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)
Eligibility Criteria
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Inclusion Criteria
* Patients with segmental vitiligo,stable since 12 months without systemic therapy or topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions
* with at least three depigmented skin lesions on the proximal extremities or trunk larger than 3x3 cm or one lesion of at least 9x3 cm
* Age \>18
* willing and able to give written informed consent
Exclusion Criteria
* Local treatment of vitiligo during the last 12 months
* Vitiligo lesions with follicular or non-follicular repigmentation
* Skin type I
* Recurrent HSV skin infections
* Hypertrophic scars
* Keloid
* Cardial insufficiency
* Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anesthesia.
* Patients who are pregnant or breast-feeding
* Patients not competent to understand the procedures involved
* Patients with atypical nevi
* Patients with a personal history of melanoma or non-melanoma skin cancer
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Lisa Komen
Drs.
Locations
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The Netherlands Institute for pigment disorders, AMC
Amsterdam, , Netherlands
Countries
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Other Identifiers
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METC2012_052
Identifier Type: -
Identifier Source: org_study_id