Autologous cell suspension grafting using ReCell in vitiligo and piebaldism patients: a randomized controlled pilot study
- Conditions
- leucoderma10035023
- Registration Number
- NL-OMON37399
- Lead Sponsor
- Stichting Nederlands Instituut voor Pigmentstoornissen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Patients with segmental vitiligo or piebaldism under medical treatment at the Netherlands Institute for Pigment Disorders
Age >18
Patient is willing and able to give written informed consent
Segmental vitiligo stable since 12 months without systemic therapy or 6 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions.
At least three vitiligo lesions on the proximal extremities or trunk larger than 3x3 cm or one vitiligo
UV therapy or systemic immunosuppressive treatment during the last 12 months
Local treatment of vitiligo during the last 12 months
Vitiligo lesions with folliculair or non-folliculair repigmentations
Skin type I and II
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 what the procedures involved
Patients with a personal history of melanoma or non-melanoma skin cancer
Patients with a first degree relative with melanoma skin cancer
Patients with atypical nevi.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter/endpoint:<br /><br>* Objective assessment of the degree of repigmentation 6 months after<br /><br>autologous epidermal cell suspension grafting. Assessment will be done by<br /><br>standardized (UVA) photographs and a digital image analysis system. A Canon G6<br /><br>is used under standardized circumstances (camera setting, distance and UVA<br /><br>flash) to obtain digital images before and after treatment. Software based on<br /><br>Matlab will be used to analyse the images and to calculate the depigmented<br /><br>surface. By comparing pre- and post treatment images, the surface showing<br /><br>repigmentation can be computed.<br /><br>* Visual assessment of side effects per treatment region (hyper pigmentation,<br /><br>hypo pigmentation and scar on a scale from 0-3) will be done by a blinded<br /><br>investigator.<br /><br>* General outcome will be assessed by the patient per treatment region on a<br /><br>scale from 0-3 (Poor, Moderate, Good, and Excellent). </p><br>
- Secondary Outcome Measures
Name Time Method <p>* The superfluous of the suspension will be used for cellular analyses, to<br /><br>investigate the density of viable melanocytes, keratinocytes, stemcells, viable<br /><br>melanocytes and keratinocytes in the cell suspension.<br /><br>* Adverse events of the procedure will be documented</p><br>