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TerminatedNCT04271501Updated Mar 14, 2023

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

An interventional study of Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB) and RECELL 1:5 and Ultraviolet Lamp (UVB) in Vitiligo, sponsored by Avita Medical. Terminated at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Avita Medical · Not applicable, Interventional, and Device feasibility

Why this study was terminated
Suspended and Terminated to focus on CTP009 (NCT04547998) Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions

From the registry’s dates

  • Primary completion was Aug 2021, 5 years 1 month ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Vitiligo

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Keywords

  • Vitiligo
03

In context

Vitiligo

298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.

This study's enrollment of 5 is below the median of 30 across 227 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Avita Medical is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
5 participants (actual)

Study arms

  • 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)

  • 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)

  • 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)

  • 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)

Interventions

  • ProcedureMelanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)

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

  • DeviceRECELL 1:5 and Ultraviolet Lamp (UVB)

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

  • DeviceRECELL 1:10 and Ultraviolet Lamp (UVB)

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

  • DeviceRECELL 1:20 and Ultraviolet Lamp (UVB)

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

06

What researchers measure

Primary outcomes

  1. Repigmentation

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

    Time frame: 24 weeks

Secondary outcomes

  1. 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%)

    Time frame: 4, 12 and 24 weeks

  2. Responders

    Proportion of treated lesions achieving ≥80% or \<80% repigmentation as assessed by a Blinded Evaluator.

    Time frame: 24 weeks

  3. Subject Repigmentation Rating

    Ratings of poor, moderate, good, or excellent

    Time frame: 4, 12 and 24 weeks

  4. Blinded Evaluator Color Matching

    Assessment of color matching (0-3: poor, moderate, good, excellent) inclusive of hypopigmentation and hyperpigmentation

    Time frame: 4, 12 and 24 weeks

07

Study locations

1 site
  • University of Massachusetts
    Worcester, Massachusetts 01655, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04271501
Lead sponsor
Avita Medical
Responsible party
Sponsor
First posted
Feb 17, 2020
Start date
Sep 25, 2020
Primary completion
Aug 24, 2021
Completion
Aug 24, 2021
Last update
Mar 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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