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

NCT ID: NCT04271501

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2021-08-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: DOUBLE

Study Groups

Control

Area without surgical intervention. Ultraviolet Lamp (UVB)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Melanocyte-Keratinocyte Transplantation

Autologous skin cell suspension prepared by laboratory based melanocyte-keratinocyte transplantation procedure technique applied to a surgically prepared area of depigmentation

Group Type: ACTIVE_COMPARATOR

Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)

Intervention Type: PROCEDURE

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

RECELL 1:5

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

Group Type: EXPERIMENTAL

RECELL 1:5 and Ultraviolet Lamp (UVB)

Intervention Type: DEVICE

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

RECELL 1:10

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

Group Type: EXPERIMENTAL

RECELL 1:10 and Ultraviolet Lamp (UVB)

Intervention Type: DEVICE

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

RECELL 1:20

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

Group Type: EXPERIMENTAL

RECELL 1:20 and Ultraviolet Lamp (UVB)

Intervention Type: DEVICE

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

Interventions

Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)

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

Intervention Type: PROCEDURE

RECELL 1:5 and Ultraviolet Lamp (UVB)

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avita Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Massachusetts

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

CTP008

Identifier Type: -

Identifier Source: org_study_id