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MT2015-36 : Study of Epidermal Grafting Using the CelluTome Epidermal Harvesting System for the Treatment of Individual Lesions in persons with Epidermolysis Bullosa

Completed

The primary study objective is to achieve > 50% wound closure within 12 weeks of skin grafting. Secondary objectives are to [1] assess safety, longevity and functionality of grafted skin in the recipient over the period of 1 year, [2] measure changes in quality of life through pain, itching and general QOL questionnaires and [3] safety and seamless, scar-free healing of the body sites of the donor from which epidermis has been harvested over the period of 1 year.

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This study is NOT accepting healthy volunteers
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)
• Healthy on physical examination in the opinion of the evaluating provider
• Negativity for Hepatitis B and C, HIV, and HTLV1/2 within 30 days of donation
• Voluntary written consent (donor or parent/guardian for minors with assent) prior to any research related procedures

Device: Cellutome Epidermal Harvesting System

Epidermolysis Bullosa

Jakub Tolar - tolar003@umn.edu
Christen Ebens
N/A
1512M81884
NCT02670837
See this study on ClinicalTrials.gov

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