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Autologous Cell Suspension Grafting Using ReCell in Vitiligo and Piebaldism Patients

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

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 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


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



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458417


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

Publications:

Responsible Party: Netherlands Institute for Pigment Disorders
ClinicalTrials.gov Identifier: NCT02458417     History of Changes
Other Study ID Numbers: NL49720.018.14
First Posted: June 1, 2015    Key Record Dates
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