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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
34
University of Minnesota Masonic Cancer Center and Medical Center
Minneapolis, Minnesota, United States
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
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