An interventional study of Cellutome Epidermal Harvesting System in Epidermolysis Bullosa, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Supportive care
Few but persistent wounds often remain even after successful hematopoietic cell transplantation for systemic genodermatosis epidermolysis bullosa (EB). The investigators propose local wound therapy using epidermal skin grafting from the same donor that provided the hematopoietic graft, or from the same EB individual with a mosaic (naturally gene corrected) skin. In both cases permissive immune system and skin chimerism is expected to enable long-term epidermal engraftment and wound healing. The investigators will use FDA approved vacuum device (CelluTome®, Regulation number 878.4820) that enables scar-free harvesting of epidermis and its transfer on a non-adherent silicone dressing (Adaptic) to the recipient as a wound dressing.
126 studies on the registry are indexed under Epidermolysis Bullosa; 23 are open to participants now.
This study's enrollment of 34 is above the median of 11 across 95 interventional studies indexed under Epidermolysis Bullosa.
Browse Epidermolysis Bullosa studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patient (Recipient)
Cell harvest from previous hematopoietic cell transplantation (HCT) donor (Arm A) - not applicable if Arm B
At least 6 months after hematopoietic cell transplantation with donor chimerism
Self-donation (Arm B) - not applicable if Arm A
Skin Graft Donor (either hematopoietic cell transplantation donor for the EB patient [Arm A] or EB patient herself/himself [Arm B])
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.
Device: Cellutome Epidermal Harvesting System
Cells are harvested from the subject using Cellutome, then transferred via Adaptic dressing to that subject's wound with up to 3 harvest sites/treated wound sites on day 0.
Device: Cellutome Epidermal Harvesting System
Percentage of Grafts Successfully Treated
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.
Time frame: 12 weeks after grafting
Participants With Lesion Free Skin
Participants without Squamous cell carcinoma (SCC) at graft site. Wound reassessments will be performed via photographs and follow-up visits.
Time frame: 1 year after grafting
Longevity of Grafted Skin
Percentage 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.
Time frame: 1 year after grafting
Percentage Change of a Patient's IScorEB Assessment Score
Measure 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.
Time frame: Baseline and 6 weeks
Percentage Change of a Patient's IScoreEB Assessment Score
Measure 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.
Time frame: Baseline and 12 weeks
Scar-free Healing of the Body Sites of the Donor
Percentage of donors with no evidence of non-healed skin. Wound reassessments will be performed via photographs and follow-up visits.
Time frame: 1 year after grafting
| Milestone | Graft From HCT Donor | Donor | Self-Donor |
|---|---|---|---|
| Started | 17 | 17 | 0 |
| Completed | 15 | 17 | 0 |
| Not completed | 2 | 0 | 0 |
| Withdrew: Death | 2 | 0 | 0 |
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.
| Percentage of grafts | Graft From HCT Donor |
|---|---|
| Percentage of Grafts Successfully Treated | 78 (63 to 89) |
Participants without Squamous cell carcinoma (SCC) at graft site. Wound reassessments will be performed via photographs and follow-up visits.
| Percentage of participants | Graft From HCT Donor |
|---|---|
| Participants With Lesion Free Skin | 100 (80 to 100) |
Percentage 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.
| Percentage of participants | Graft From HCT Donor |
|---|---|
| Longevity of Grafted Skin | 34 (21 to 50) |
Measure 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.
| Percent change | Graft From HCT Donor |
|---|---|
| Change in pain QOL score | -2.1 (-31.5 to 27.3) |
| Change in itch QOL score | -1.9 (-33.9 to 30.1) |
| Change in General QOL score | 3.1 (-13.7 to 19.8) |
Measure 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.
| Percent change | Graft From HCT Donor |
|---|---|
| Change in pain QOL score | -8.1 (-32.5 to 16.3) |
| Change in itch QOL score | -10.4 (-50.1 to 29.2) |
| Change in general QOL score | -0.4 (-18 to 17.2) |
Percentage of donors with no evidence of non-healed skin. Wound reassessments will be performed via photographs and follow-up visits.
| Percentage of participants | Donor |
|---|---|
| Scar-free Healing of the Body Sites of the Donor | 100 (80 to 100) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Graft From HCT Donor | 2/17 (11.8%) | 0/17 (0%) | 0/17 (0%) |
| Donor | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Graft From HCT Donor | Donor | Total |
|---|---|---|---|
| <=18 years | 15 | 10 | 25 |
| Between 18 and 65 years | 2 | 7 | 9 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Graft From HCT Donor | Donor | Total |
|---|---|---|---|
| Female | 8 | 15 | 23 |
| Male | 9 | 2 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Graft From HCT Donor | Donor | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 16 | 16 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Graft From HCT Donor | Donor | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 15 | 12 | 27 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 4 | 5 |
| Region of Enrollment(participants) | Graft From HCT Donor | Donor | Total |
|---|---|---|---|
| United States | 17 | 17 | 34 |
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Masonic Cancer Center, University of Minnesota