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Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

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ClinicalTrials.gov Identifier: NCT01640678
Recruitment Status : Unknown
Verified August 2013 by Lisa Komen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Active, not recruiting
First Posted : July 16, 2012
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):
Lisa Komen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE July 12, 2012
First Posted Date  ICMJE July 16, 2012
Last Update Posted Date August 5, 2013
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
degree of repigmentation [ Time Frame: 6 months ]
Objective assessment of the degree of repigmentation 6 months after autologous epidermal cell suspension grafting. Assessment will be done by standardized photographs and a digital image analysis system.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
  • Visual assessment of side effects per treatment region [ Time Frame: 6 months ]
    Visual assessment of side effects per treatment region (hyper pigmentation, hypo pigmentation and scar on a scale from 0-3) will be done by a blinded investigator
  • General outcome assessed by the patient [ Time Frame: 6 months ]
    General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients
Official Title  ICMJE Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Pilot Study
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Piebaldism
  • Segmental Vitiligo
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Experimental: ReCell epidermal cell suspension grafting
    CO2 laser abrasion + ReCell epidermal cell suspension + UV-therapy
    Intervention: Procedure: ReCell epidermal cell suspension grafting
  • Active Comparator: 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)
    Intervention: Procedure: CO2 laser abrasion + UV-therapy
  • No Intervention: No treatment + UV-therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 12, 2012)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patient with piebaldism
  • 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:

  • UV therapy or systemic immunosuppressive treatment during the last 12 months
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01640678
Other Study ID Numbers  ICMJE METC2012_052
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa Komen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP