Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions

Study Overview
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Brief Summary
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Prospective randomized within-subject controlled feasibility study to evaluate the clinical performance of RECELL for repigmentation of stable, depigmented lesions. The trial will evaluate 50 matched, stable depigmented areas from 10 subjects.

Official Title
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A Prospective Blinded Randomized Within-Subject Controlled Clinical Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure (MKTP) for Repigmentation of Stable Vitiligo Lesions

Conditions
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Vitiligo

Intervention / Treatment
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* Procedure: Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)
* Device: RECELL 1:5 and Ultraviolet Lamp (UVB)
* Device: RECELL 1:10 and Ultraviolet Lamp (UVB)
* Device: RECELL 1:20 and Ultraviolet Lamp (UVB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria to be eligible: Focal, segmental or generalized (i.e., nonsegmental) vitiligo documented as stable (no new lesions nor lesions expanding in size within the preceding 12 months, regardless of whether the lesions are intended for treatment in this study). The patient has not undergone topical treatment (e.g., steroids) for the study lesion within the past 60 days. The patient has not undergone phototherapy (e.g., NB-UVB) for the study lesion within the past 6 months. The patient is a candidate for surgical intervention for treatment of a depigmented area, defined as: the patient has been compliant but has not satisfactorily responded to topical therapy and a minimum of 3 months of phototherapy. Five discrete 3cm by 3cm areas are available for treatment within the depigmented lesion. The 5 study areas must be similarly sun exposed. The extent of leukotrichia must be similar between the five study areas. The patient is ≥ 22 years of age. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol. The patient agrees to abstain from any other treatment of the study areas for the duration of the his/her participation in the study (24 weeks). The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation in the study (24 weeks). In the opinion of the investigator, the patient and/or guardian must be able to: Understand the full nature and purpose of the study, including possible risks and adverse events, Understand instructions, and Provide voluntary written informed consent. Exclusion Criteria: Subjects who meet any of the following criteria are not eligible: The area requiring treatment is not associated with vitiligo. Study areas contain the distal phalanges. The patient in unable to undergo the treatment area preparation. Patients who are pregnant. Patients with universalis vitiligo, depigmented areas over >30% of their body surface area, or depigmented lips and fingertips (lip-tip vitiligo). Patient with a history of keloid formation. Patients who have used a tanning salon in the past 60 days. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. Current use of medications (e.g., anticoagulants such as such as heparin or warfarin) that in the investigator's opinion may compromise patient safety or trial objectives. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution. The patient has recent history (within 12 months) of Koebner phenomenon and/or confetti-like or trichrome lesions. Life expectancy is less than 1 year

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each subject serves as their own control.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Area without surgical intervention. Ultraviolet Lamp (UVB) | |
| Active Comparator: Melanocyte-Keratinocyte Transplantation<br>Autologous skin cell suspension prepared by laboratory based melanocyte-keratinocyte transplantation procedure technique applied to a surgically prepared area of depigmentation | Procedure: Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)<br>* Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas<br>|
| Experimental: RECELL 1:5<br>Regenerative epidermal suspension diluted 1:5 applied to a surgically prepared area of depigmentation | Device: RECELL 1:5 and Ultraviolet Lamp (UVB)<br>* Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation<br>|
| Experimental: RECELL 1:10<br>Regenerative epidermal suspension diluted 1:10 applied to a surgically prepared area of depigmentation | Device: RECELL 1:10 and Ultraviolet Lamp (UVB)<br>* Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation<br>|
| Experimental: RECELL 1:20<br>Regenerative epidermal suspension diluted 1:20 applied to a surgically prepared area of depigmentation | Device: RECELL 1:20 and Ultraviolet Lamp (UVB)<br>* Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repigmentation | Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorization of Repigmentation | Categorization of each study area in terms of ranges of percent repigmentation by a Blinded Evaluator (0-25%, 26-50%, 51-79%, 80-100%) | 4, 12 and 24 weeks | 
| Responders | Proportion of treated lesions achieving ≥80% or <80% repigmentation as assessed by a Blinded Evaluator. | 24 weeks | 
| Subject Repigmentation Rating | Ratings of poor, moderate, good, or excellent | 4, 12 and 24 weeks | 
| Blinded Evaluator Color Matching | Assessment of color matching (0-3: poor, moderate, good, excellent) inclusive of hypopigmentation and hyperpigmentation | 4, 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitiligo