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

March 12, 2023 updated by: Avita Medical

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Repigmentation
Time Frame: 24 weeks
Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Categorization of Repigmentation
Time Frame: 4, 12 and 24 weeks
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
Time Frame: 24 weeks
Proportion of treated lesions achieving ≥80% or <80% repigmentation as assessed by a Blinded Evaluator.
24 weeks
Subject Repigmentation Rating
Time Frame: 4, 12 and 24 weeks
Ratings of poor, moderate, good, or excellent
4, 12 and 24 weeks
Blinded Evaluator Color Matching
Time Frame: 4, 12 and 24 weeks
Assessment of color matching (0-3: poor, moderate, good, excellent) inclusive of hypopigmentation and hyperpigmentation
4, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avita Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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