Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

NCT01640678 | Unknown Phase 4

• 1 other identifier: METC2012_052
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Piebaldism; Segmental Vitiligo

Outcome Measures

Primary Outcomes (1)

• degree of repigmentation

  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.

  6 months

Secondary Outcomes (2)

• Visual assessment of side effects per treatment region

  6 months

• General outcome assessed by the patient

  6 months

Study Arms (3)

ReCell epidermal cell suspension grafting

EXPERIMENTAL

CO2 laser abrasion + ReCell epidermal cell suspension + UV-therapy

Procedure: ReCell epidermal cell suspension grafting

CO2 laser abrasion + UV-therapy

ACTIVE COMPARATOR

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

No treatment + UV-therapy

NO INTERVENTION

Interventions

ReCell epidermal cell suspension grafting PROCEDURE

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.

ReCell epidermal cell suspension grafting

CO2 laser abrasion + UV-therapy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

The Netherlands Institute for pigment disorders, AMC

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Piebaldism

Condition Hierarchy (Ancestors)

Albinism; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs.

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

NL (1)