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

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

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.

Study Overview

• Status: Terminated
• Conditions: Vitiligo
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible:

1. 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).
2. The patient has not undergone topical treatment (e.g., steroids) for the study lesion within the past 60 days.
3. The patient has not undergone phototherapy (e.g., NB-UVB) for the study lesion within the past 6 months.
4. 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.
5. Five discrete 3cm by 3cm areas are available for treatment within the depigmented lesion.
6. The 5 study areas must be similarly sun exposed.
7. The extent of leukotrichia must be similar between the five study areas.
8. The patient is ≥ 22 years of age.
9. The patient is willing and able to comply with post-treatment at-home phototherapy and all follow-up evaluations required by the study protocol.
10. 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).
11. 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).

12. In the opinion of the investigator, the patient and/or guardian must be able to:

    1. Understand the full nature and purpose of the study, including possible risks and adverse events,
    2. Understand instructions, and
    3. Provide voluntary written informed consent.

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible:

1. The area requiring treatment is not associated with vitiligo.
2. Study areas contain the distal phalanges.
3. The patient in unable to undergo the treatment area preparation.
4. Patients who are pregnant.
5. Patients with universalis vitiligo, depigmented areas over >30% of their body surface area, or depigmented lips and fingertips (lip-tip vitiligo).
6. Patient with a history of keloid formation.
7. Patients who have used a tanning salon in the past 60 days.
8. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
9. 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.
10. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
11. The patient has recent history (within 12 months) of Koebner phenomenon and/or confetti-like or trichrome lesions.
12. Life expectancy is less than 1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Avita Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Actual): August 24, 2021
• Study Completion (Actual): August 24, 2021

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Vitiligo
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: CTP008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes