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Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

This study is currently recruiting participants.
Verified July 2012 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
Lisa Komen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01640678
First received: July 12, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Piebaldism
Segmental Vitiligo
 Procedure: ReCell epidermal cell suspension grafting
Procedure: CO2 laser abrasion + UV-therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • degree of repigmentation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Visual assessment of side effects per treatment region [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent)


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReCell epidermal cell suspension grafting
CO2 laser abrasion + ReCell epidermal cell suspension + UV-therapy
 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.
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)
 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)
No Intervention: No treatment + UV-therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640678

Contacts
Contact: Lisa Komen, Drs. 0031205667792 l.komen@amc.uva.nl
Contact: Info SNIP, . 0031 20 5666955 infosnip@amc.nl

Locations
Netherlands
The Netherlands Institute for pigment disorders, AMC Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Lisa Komen, Drs.     0031 20 5667792     l.komen@amc.uva.nl    
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: Lisa Komen, Drs., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01640678     History of Changes
Other Study ID Numbers: METC2012_052
Study First Received: July 12, 2012
Last Updated: July 12, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Ministry of Health, Welfare and Sport

Additional relevant MeSH terms:
Albinism
Vitiligo
Piebaldism
Hypopigmentation
Pigmentation Disorders
Skin Diseases
 Eye Diseases, Hereditary
Genetic Diseases, Inborn
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Skin Diseases, Genetic
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013