Trial Outcomes & Findings for Study of Cellutome System for Treatment of Individual Lesions in EB Pts (NCT NCT02670837)
NCT ID: NCT02670837
Last Updated: 2024-04-09
Results Overview
If the body surface area affected by the wound is at least 50% lower at 12 weeks relative to baseline, the graft will be considered successful.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
12 weeks after grafting
Results posted on
2024-04-09
Participant Flow
Unit of analysis: grafts
Participant milestones
| Measure |
Graft From HCT Donor
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
Cellutome Epidermal Harvesting System
|
Donor
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound.
Cellutome Epidermal Harvesting System
|
Self-Donor
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
Cellutome Epidermal Harvesting System
|
|---|---|---|---|
|
Overall Study
STARTED
|
17 51
|
17 0
|
0 0
|
|
Overall Study
COMPLETED
|
15 45
|
17 0
|
0 0
|
|
Overall Study
NOT COMPLETED
|
2 6
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Graft From HCT Donor
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
Cellutome Epidermal Harvesting System
|
Donor
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound.
Cellutome Epidermal Harvesting System
|
Self-Donor
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
Cellutome Epidermal Harvesting System
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
0
|
0
|
Baseline Characteristics
Study of Cellutome System for Treatment of Individual Lesions in EB Pts
Baseline characteristics by cohort
| Measure |
Graft From HCT Donor
n=17 Participants
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
Cellutome Epidermal Harvesting System
|
Donor
n=17 Participants
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
Cellutome Epidermal Harvesting System
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
17 participants
n=107 Participants
|
34 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after graftingIf the body surface area affected by the wound is at least 50% lower at 12 weeks relative to baseline, the graft will be considered successful.
Outcome measures
| Measure |
Graft From HCT Donor
n=45 grafts
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
|
|---|---|
|
Percentage of Grafts Successfully Treated
|
78 Percentage of grafts
Interval 63.0 to 89.0
|
SECONDARY outcome
Timeframe: 1 year after graftingParticipants without Squamous cell carcinoma (SCC) at graft site. Wound reassessments will be performed via photographs and follow-up visits.
Outcome measures
| Measure |
Graft From HCT Donor
n=15 Participants
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
|
|---|---|
|
Participants With Lesion Free Skin
|
100 Percentage of participants
Interval 80.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 year after graftingPercentage of patients who have had a 6 week period of lesion free skin by the time they are 1 year post grafting. Wound reassessments will be performed via photographs and follow-up visits.
Outcome measures
| Measure |
Graft From HCT Donor
n=15 Participants
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
|
|---|---|
|
Longevity of Grafted Skin
|
34 Percentage of participants
Interval 21.0 to 50.0
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksMeasure percent of changes in quality of life (QOL) through pain, itching, and general QOL IScorEB questionnaire. Scores can range from 16 to 112. The QOLS scores are summed so that a higher score indicates higher quality of life.
Outcome measures
| Measure |
Graft From HCT Donor
n=13 Participants
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
|
|---|---|
|
Percentage Change of a Patient's IScorEB Assessment Score
Change in pain QOL score
|
-2.1 Percent change
Interval -31.5 to 27.3
|
|
Percentage Change of a Patient's IScorEB Assessment Score
Change in itch QOL score
|
-1.9 Percent change
Interval -33.9 to 30.1
|
|
Percentage Change of a Patient's IScorEB Assessment Score
Change in General QOL score
|
3.1 Percent change
Interval -13.7 to 19.8
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksMeasure percent of changes in quality of life (QOL) through pain, itching, and general QOL IScorEB questionnaire. Scores can range from 16 to 112. The QOLS scores are summed so that a higher score indicates higher quality of life.
Outcome measures
| Measure |
Graft From HCT Donor
n=12 Participants
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
|
|---|---|
|
Percentage Change of a Patient's IScoreEB Assessment Score
Change in pain QOL score
|
-8.1 Percent change
Interval -32.5 to 16.3
|
|
Percentage Change of a Patient's IScoreEB Assessment Score
Change in itch QOL score
|
-10.4 Percent change
Interval -50.1 to 29.2
|
|
Percentage Change of a Patient's IScoreEB Assessment Score
Change in general QOL score
|
-0.4 Percent change
Interval -18.0 to 17.2
|
SECONDARY outcome
Timeframe: 1 year after graftingPercentage of donors with no evidence of non-healed skin. Wound reassessments will be performed via photographs and follow-up visits.
Outcome measures
| Measure |
Graft From HCT Donor
n=17 Participants
Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.
|
|---|---|
|
Scar-free Healing of the Body Sites of the Donor
|
100 Percentage of participants
Interval 80.0 to 100.0
|
Adverse Events
Graft From HCT Donor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Donor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christen Ebens
University of Minnesota, Masonic Cancer Center
Phone: (612) 626-5654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place