Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

• ClinicalTrials.gov Identifier: NCT02458417
• Recruitment Status: Completed
• First Posted: June 1, 2015
• Last Update Posted: April 4, 2017
• Sponsor: Netherlands Institute for Pigment Disorders
• Collaborator: Avita Medical
• Information provided by (Responsible Party): Netherlands Institute for Pigment Disorders

Study Description

Brief Summary:

The purpose of this study is to assess the efficacy and safety of ReCell grafting after CO2 laser abrasion with superficial full surface ablation, fractional laser treatment and conventional (deep) full surface CO2 laser ablation, to assess the practical aspects and the patient reported outcome and to assess the cellular composition of the graft.

Condition or disease	Intervention/treatment	Phase
Segmental Vitiligo; Piebaldism	Device: ReCell; Device: Full surface CO2 laser 200 mJ; Device: Full surface CO2 laser 150 mJ; Device: Fractional CO2 laser 7.5 mJ, 20%	Phase 4

Detailed Description:

Autologous epidermal cell suspension grafting is an effective method of surgical treatment in vitiligo, which is suitable for treating large areas with good cosmetic results. The ReCell Autologous Cell Harvesting Device (Avita Medical Europe Limited, Cambridge, UK) is a device which, compared to other forms of autologous epidermal cell suspension grafting, is easier in use showing similar results. With this device an epidermal cell suspension is created from a split skin graft, usually taken from the hip region. Currently, conventional ablative (full surface de-epidermisation) laser treatment in different laser settings is used as pre-treatment to prepare the acceptor site for transplantation. There is no evidence for the laser settings used and no studies are available on the use of a fractional laser as pre-treatment in autologous cell suspension grafting using ReCell (ReCell grafting). The investigators hypothesize that more superficial conventional ablative laser treatment and fractional ablative laser treatment are as effective as the current pre-treatment, whereas these treatments are less invasive, provide faster healing and prevent side effects like persisting erythema and scars. Furthermore, infiltration anaesthesia is not necessary with these less invasive treatments.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients: a Randomized Controlled Study on the Recipient Site Preparation
• Study Start Date: May 2015
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Full surface CO2 laser 200mJ + ReCell; This test region will receive full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 209 µm) and density 3. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.	Device: ReCell; A split-thickness skin biopsy will be taken from the hip region of the patient. The skin biopsy that is obtained will be treated in the ReCell kit (Avita Medical Europe Ltd, Cambridge, UK): it will be placed in the heated enzyme solution, containing trypsin, in the device for 15-20 minutes to allow cell disaggregation. After that period, the biopsy will be taken from the enzyme solution and will be dipped in sodium lactate buffer solution. The biopsy will then be scraped to disaggregate the cells from the dermal epidermal junction. The epidermal cells are drawn up in a syringe. The prepared suspension will be dripped on both donor and acceptor site.; Other Name: ReCell autologous cell suspension grafting; Device: Full surface CO2 laser 200 mJ; Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 144 µm) and density 3
Experimental: Full surface CO2 laser 150mJ + ReCell; This test region will receive full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.	Device: ReCell; A split-thickness skin biopsy will be taken from the hip region of the patient. The skin biopsy that is obtained will be treated in the ReCell kit (Avita Medical Europe Ltd, Cambridge, UK): it will be placed in the heated enzyme solution, containing trypsin, in the device for 15-20 minutes to allow cell disaggregation. After that period, the biopsy will be taken from the enzyme solution and will be dipped in sodium lactate buffer solution. The biopsy will then be scraped to disaggregate the cells from the dermal epidermal junction. The epidermal cells are drawn up in a syringe. The prepared suspension will be dripped on both donor and acceptor site.; Other Name: ReCell autologous cell suspension grafting; Device: Full surface CO2 laser 150 mJ; Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3
Experimental: Fractional CO2 laser 7.5mJ 20% + ReCell; This test region will receive pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density. After pretreatment ReCell autologous epidermal cell suspension will be applied on this test region.	Device: ReCell; A split-thickness skin biopsy will be taken from the hip region of the patient. The skin biopsy that is obtained will be treated in the ReCell kit (Avita Medical Europe Ltd, Cambridge, UK): it will be placed in the heated enzyme solution, containing trypsin, in the device for 15-20 minutes to allow cell disaggregation. After that period, the biopsy will be taken from the enzyme solution and will be dipped in sodium lactate buffer solution. The biopsy will then be scraped to disaggregate the cells from the dermal epidermal junction. The epidermal cells are drawn up in a syringe. The prepared suspension will be dripped on both donor and acceptor site.; Other Name: ReCell autologous cell suspension grafting; Device: Fractional CO2 laser 7.5 mJ, 20%; Pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density.
No Intervention: Control; No intervention

Outcome Measures

Primary Outcome Measures :

1. Repigmentation [ Time Frame: 6 months after intervention ]
   Assessment will be done by sheets and a digital image analysis system. To assess the pigmentation, the contours of pigmentation are copied on a transparent sheet before and six months after treatment, after which the sheets are scanned using a predefined resolution. By comparing pre- and post-treatment pictures, the relative surface showing repigmentation expressed as percentage of the selected treated patch are computed.

Secondary Outcome Measures :

1. PhGA [ Time Frame: 6 months after intervention ]
   Blinded physician's assessment of repigmentation. Repigmentation will be classified as follows: 0-25%, 26-50%, 51-75%, 76-95%, 96-100% six months.
2. Side effects [ Time Frame: 6 months after intervention ]
   Visual assessment of side effects per treatment region (erythema, hyperpigmentation, hypopigmentation and scar on a scale from 0-3) will be done by a blinded investigator six months.
3. Reepithelialization [ Time Frame: 1 week after intervention ]
   One week after grafting reepithelialization will be assessed by a blinded physician and estimated on a 0 to 100% scale.
4. Colour difference [ Time Frame: 6 months after intervention ]
   Colour difference i.e. the difference between normal pigmentation, erythema, and hyperpigmentation will be assessed with a DermaSpectrometer (Cortex Technology ApS, Hadsund, Denmark)
5. PGA [ Time Frame: 6 months after intervention ]
   General outcome will be assessed by the patient per treatment region on a scale from 0-3 (Poor, Moderate, Good, and Excellent).
6. Pain [ Time Frame: 1 week after intervention ]
   One week after grafting, pain will be assessed after grafting on a 100 mm visual analogue scale (VAS) per treatment region
7. Cell count [ Time Frame: up to six hours ]
   The superfluous of the suspension will be used for flow cytometric analyses of the cellular composition of the graft.

Other Outcome Measures:

1. Skin type [ Time Frame: week 0 ]
   Fitzpatrick skin type
2. VIDA score [ Time Frame: week 0 ]
   Classification of disease activity according to VIDA scale
3. Duration of disease [ Time Frame: week 0 ]
   Duration of disease

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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 12 months without topical therapy as defined by the absence of new lesions and/or enlargement of existing lesions.
• At least four depigmented lesions on the proximal extremities or trunk larger than 3x3 cm or one depigmented lesion on the proximal extremities or trunk of at least 12x3 cm.

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 repigmentations
• Skin type I
• Recurrent HSV skin infections
• Hypertrophic scars
• Keloid
• Cardiac insufficiency
• Patients with a history of hypersensitivity to (UVB or UVA) light and/or allergy to local anaesthesia.
• Patients who are pregnant or breast-feeding
• Patients not competent to understand what the procedures involves
• Patients with a personal history of melanoma or non-melanoma skin cancer
• Patients with atypical nevi.
• Known allergy to clarithromycin

Contacts and Locations

Locations

Netherlands

Netherlands Institute for Pigment disorders

Amsterdam, Netherlands, 1105 AZ

Sponsors and Collaborators

Netherlands Institute for Pigment Disorders

Avita Medical

Investigators

• Principal Investigator: Albert Wolkerstorfer, MD, PhD; Netherlands Institute for Pigment Disorders, Department of Dermatology, Academic Medical Center, University of Amsterdam
• Study Director: Menno A. De Rie, MD, PhD; Department of Dermatology, Academic Medical Center, University of Amsterdam

More Information

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• Responsible Party: Netherlands Institute for Pigment Disorders
• ClinicalTrials.gov Identifier: NCT02458417
• Other Study ID Numbers: NL49720.018.14
• First Posted: June 1, 2015
• Last Update Posted: April 4, 2017
• Last Verified: May 2015

Keywords provided by Netherlands Institute for Pigment Disorders:

Ablative laser; Fractional laser; Vitiligo; Piebaldism; Cell suspension grafting

Additional relevant MeSH terms:

Piebaldism; Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Albinism; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Metabolic Diseases