Study of Cellutome System for Treatment of Individual Lesions in EB Pts (NCT02670837) | Clinical Trial Compass
CompletedNot Applicable
Study of Cellutome System for Treatment of Individual Lesions in EB Pts
United States34 participantsStarted 2016-08-04
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient (Recipient)
* Diagnosis of Dystrophic Epidermolysis Bullosa (DEB) or Junctional Epidermolysis Bullosa (JEB) with at least one wound, visibly free from infection (or previously treated) and meets the eligibility for Arm A or Arm B based on the skin graft source:
* 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
* Peripheral blood donor chimerism should be measured within 21 days of grafting and be \>/= 5% and stable. Stability of chimerism will be determined by the protocol team and based on 3 peripheral blood chimerism values at least 1 month apart.
* No history of pre-BMT autoimmune cytopenias
* Off immune suppressive therapy
* Original transplant donor is available and willing to be the epidermis donor
* Self-donation (Arm B) - not applicable if Arm A
* Proven somatic reversion
* Site for skin grafting free of cellulitis and any other clinically evident abnormalities
* Meets donor eligibility
* Insurance pre-authorization for procedure, if applicable
* Voluntary written consent (patient or parent/guardian for minors with assent) prior to any research related procedures or treatment.
Skin Graft Donor (either hematopoietic cell transplantation donor for the EB patient \[Arm A\] or EB patient herself/himself \[Arm B\])
* Age \> 2 years (based on prior safety testing of the device)
* He…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Grafts Successfully Treated
Timeframe: 12 weeks after grafting
Trial details
NCT IDNCT02670837
SponsorMasonic Cancer Center, University of Minnesota