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

Not Applicable

Terminated

• Conditions: Vitiligo
• Interventions: Procedure: Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)

• Registration Number: NCT04271501
• Lead Sponsor: Avita Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-09-25
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melanocyte-Keratinocyte Transplantation	Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)	Autologous skin cell suspension prepared by laboratory based melanocyte-keratinocyte transplantation procedure technique applied to a surgically prepared area of depigmentation

Primary Outcome Measures

Name	Time	Method
Repigmentation	24 weeks	Percent area repigmented for each study area compared to standardized reference photos by a Blinded Evaluator

Secondary Outcome Measures

Name	Time	Method
Blinded Evaluator Color Matching	4, 12 and 24 weeks	Assessment of color matching (0-3: poor, moderate, good, excellent) inclusive of hypopigmentation and hyperpigmentation
Categorization of Repigmentation	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%)
Responders	24 weeks	Proportion of treated lesions achieving ≥80% or \<80% repigmentation as assessed by a Blinded Evaluator.
Subject Repigmentation Rating	4, 12 and 24 weeks	Ratings of poor, moderate, good, or excellent

Trial Locations

Locations (1)

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States