Trial Outcomes & Findings for Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions (NCT NCT04547998)
NCT ID: NCT04547998
Last Updated: 2024-05-24
Results Overview
Repigmentation was evaluated by qualified members of a Central Review Committee.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Week 24
Results posted on
2024-05-24
Participant Flow
The design of this study is a within-patient comparison. Protocol enrollment is 25 (participants), with 50 interventions (2 per patient).
Unit of analysis: depigmented vitiligo lesions
Participant milestones
| Measure |
Control Intervention (UVB)
A portion of each participant's vitiligo lesion is randomly assigned to receive the Control Intervention (within-patient control): Targeted narrowband-UVB (only)
|
Investigational Intervention (Ablative Laser Resurfacing + RECELL + UVB)
A portion of each participant's vitiligo lesion is randomly allocated to receive the Investigational Treatment: Spray-On Skin™ Cells prepared using RECELL will be applied to an area prepared by ablative laser, followed by targeted narrowband UVB phototherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
25 25
|
25 25
|
|
Overall Study
COMPLETED
|
25 25
|
25 25
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
Baseline characteristics by cohort
| Measure |
All Participants (Within Patient Control)
n=25 Participants
All subjects will receive both RECELL and NV-UVB. Each subject will serve as their own Control, with a depigmented area receiving no RECELL treatment but receiving the same targeted NB-UVB as the investigational treatment area. Study treatment areas will be randomly assigned as Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B.
Spray-On Skin™ Cells 1:20 followed by NB-UVB: Skin cell suspension at expansion ratio 1:20 (donor area : recipient area), prepared using the RECELL System, will be applied to an ablated (de-epithelialized) area of depigmentation, followed by targeted phototherapy using NB-UVB.
NB-UVB only: Each subject will serve as their own control, with a portion (or similar) depigmented lesion receiving the same targeted NB-UVB without application of skin cell suspension.
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|---|---|
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Age, Continuous
|
41.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: ITT
Repigmentation was evaluated by qualified members of a Central Review Committee.
Outcome measures
| Measure |
Control Intervention (UVB)
n=25 depigmented vitiligo lesions
A portion of each participant's vitiligo lesion is randomly assigned to receive the Control Intervention (within-patient control): Targeted narrowband-UVB phototherapy (only)
|
Investigational Intervention (Ablative Laser Resurfacing + RECELL + UVB)
n=25 depigmented vitiligo lesions
A portion of each participant's vitiligo lesion is randomly allocated to receive the Investigational Treatment: Spray-On Skin™ Cells prepared using RECELL will be applied to an area prepared by ablative laser, followed by targeted narrowband UVB phototherapy.
|
|---|---|---|
|
Incidence of ≥80% Study Area Repigmentation
|
0 study areas
|
9 study areas
|
SECONDARY outcome
Timeframe: Week 24Population: ITT
Expert Central Review Committee categorization of the amount of area repigmented (0-25%, 26-50%, 51-79% and 80-100%). This is visual estimation of the vitiligo lesion area that has repigmented, with reference to training images. Higher %repigmentation is a better outcome.
Outcome measures
| Measure |
Control Intervention (UVB)
n=25 depigmented vitiligo lesions
A portion of each participant's vitiligo lesion is randomly assigned to receive the Control Intervention (within-patient control): Targeted narrowband-UVB phototherapy (only)
|
Investigational Intervention (Ablative Laser Resurfacing + RECELL + UVB)
n=25 depigmented vitiligo lesions
A portion of each participant's vitiligo lesion is randomly allocated to receive the Investigational Treatment: Spray-On Skin™ Cells prepared using RECELL will be applied to an area prepared by ablative laser, followed by targeted narrowband UVB phototherapy.
|
|---|---|---|
|
Repigmentation Category
Repigmentation Category: 0%
|
5 depigmented vitiligo lesions
|
3 depigmented vitiligo lesions
|
|
Repigmentation Category
Repigmentation Category: 1 to 25%
|
13 depigmented vitiligo lesions
|
6 depigmented vitiligo lesions
|
|
Repigmentation Category
Repigmentation Category: 26 to 50%
|
4 depigmented vitiligo lesions
|
2 depigmented vitiligo lesions
|
|
Repigmentation Category
Repigmentation Category: 51 to 79%
|
3 depigmented vitiligo lesions
|
5 depigmented vitiligo lesions
|
|
Repigmentation Category
Repigmentation Category: 80 to 99%
|
0 depigmented vitiligo lesions
|
9 depigmented vitiligo lesions
|
|
Repigmentation Category
Repigmentation Category: 100%
|
0 depigmented vitiligo lesions
|
0 depigmented vitiligo lesions
|
SECONDARY outcome
Timeframe: Week 24Population: ITT
The Expert Central Review Committee visually judged the quality of repigmentation in terms of how closely it matches with the normal pigmentation seen in the surrounding area. The rating scale consists of poor, moderate, good, and excellent. Color matching can only be evaluated in instances of \>0% repigmentation.
Outcome measures
| Measure |
Control Intervention (UVB)
n=20 study areas with >0% repigmentation
A portion of each participant's vitiligo lesion is randomly assigned to receive the Control Intervention (within-patient control): Targeted narrowband-UVB phototherapy (only)
|
Investigational Intervention (Ablative Laser Resurfacing + RECELL + UVB)
n=22 study areas with >0% repigmentation
A portion of each participant's vitiligo lesion is randomly allocated to receive the Investigational Treatment: Spray-On Skin™ Cells prepared using RECELL will be applied to an area prepared by ablative laser, followed by targeted narrowband UVB phototherapy.
|
|---|---|---|
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Color Matching
Color Matching Category: Poor
|
0 study areas with >0% repigmentation
|
1 study areas with >0% repigmentation
|
|
Color Matching
Color Matching Category: Moderate
|
4 study areas with >0% repigmentation
|
6 study areas with >0% repigmentation
|
|
Color Matching
Color Matching Category: Good
|
12 study areas with >0% repigmentation
|
9 study areas with >0% repigmentation
|
|
Color Matching
Color Matching Category: Excellent
|
4 study areas with >0% repigmentation
|
6 study areas with >0% repigmentation
|
Adverse Events
Control Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Investigational Intervention (RECELL)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Intervention
n=25 participants at risk
All subjects will receive both RECELL and NV-UVB. Each subject will serve as their own Control, with a depigmented area receiving no RECELL treatment but receiving the same targeted NB-UVB as the investigational treatment area. Study treatment areas will be randomly assigned as Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B.
Control area intervention: NB-UVB only without application of skin cell suspension.
|
Investigational Intervention (RECELL)
n=25 participants at risk
All subjects will receive both RECELL and NV-UVB. Each subject will serve as their own Control, with a depigmented area receiving no RECELL treatment but receiving the same targeted NB-UVB as the investigational treatment area. Study treatment areas will be randomly assigned as Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B.
Investigational Intervention: Spray-On Skin™ Cells 1:20 followed by NB-UVB: Skin cell suspension at expansion ratio 1:20 (donor area : recipient area), prepared using the RECELL System, will be applied to an ablated (de-epithelialized) area of depigmentation, followed by targeted phototherapy using NB-UVB.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/25 • 52 Weeks
|
4.0%
1/25 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25 • 52 Weeks
|
4.0%
1/25 • Number of events 1 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • 52 Weeks
|
8.0%
2/25 • Number of events 2 • 52 Weeks
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
4.0%
1/25 • Number of events 1 • 52 Weeks
|
4.0%
1/25 • Number of events 1 • 52 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place