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

NCT04271501 | Terminated FDA Device

• 1 other identifier: CTP008
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitiligo

Keywords

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Repigmentation

  Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator

  24 weeks

Secondary Outcomes (4)

• Categorization of Repigmentation

  4, 12 and 24 weeks

• Responders

  24 weeks

• Subject Repigmentation Rating

  4, 12 and 24 weeks

• Blinded Evaluator Color Matching

  4, 12 and 24 weeks

Study Arms (5)

Control

NO INTERVENTION

Area without surgical intervention. Ultraviolet Lamp (UVB)

Melanocyte-Keratinocyte Transplantation

ACTIVE COMPARATOR

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)

RECELL 1:5

EXPERIMENTAL

Regenerative epidermal suspension diluted 1:5 applied to a surgically prepared area of depigmentation

Device: RECELL 1:5 and Ultraviolet Lamp (UVB)

RECELL 1:10

EXPERIMENTAL

Regenerative epidermal suspension diluted 1:10 applied to a surgically prepared area of depigmentation

Device: RECELL 1:10 and Ultraviolet Lamp (UVB)

RECELL 1:20

EXPERIMENTAL

Regenerative epidermal suspension diluted 1:20 applied to a surgically prepared area of depigmentation

Device: RECELL 1:20 and Ultraviolet Lamp (UVB)

Interventions

Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB) PROCEDURE

Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas

Melanocyte-Keratinocyte Transplantation

RECELL 1:5 and Ultraviolet Lamp (UVB) DEVICE

Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation

RECELL 1:5

RECELL 1:10 and Ultraviolet Lamp (UVB) DEVICE

Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation

RECELL 1:10

RECELL 1:20 and Ultraviolet Lamp (UVB) DEVICE

Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation

RECELL 1:20

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avita Medical: lead

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Repigmentation will be evaluated via measurement of the area repigmented and will be rated by the patient and a Blinded Evaluator (blinded to treatment allocation) using standardized photographs.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject serves as their own control.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: September 25, 2020
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

US (1)