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- Check32 days agoChange DetectedThe value on the web page has changed from 'Show more Show more Revision: v2.9.0' to 'Show less MedlinePlus Genetics related topics: Dystrophic epidermolysis bullosa MedlinePlus related topics: Genes and Gene Therapy Genetic and Rare Diseases Information Center resources: Epidermolysis Bullosa Dystrophic Epidermolysis Bullosa FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : LEAES treatment LZRSE-Col7A1 Engineered Autologous Epidermal Sheets (LEAES) Biological : LZRSE-Col7A1 Engineered Autologous Epidermal Sheets This trial will create a graft, which we call 'LEAES', of the patient's own skin that has been genetically engineered in our lab to express this missing protein. Other Names: LEAES Primary Outcome Measures Outcome Measure Measure Description Time Frame Number of Wounds by Healing Category Per Investigator Visual Assessment The graft site was clinically evaluated by the investigator with a global score of: 1) 100% to 75% healed, 2) 74% to 50% healed, 3) 49% or less healed with 100% meaning completely healed. 3, 6, 12 and 24 months post grafting Percentage Surface Area of Wound Healing Percentage of wound area will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Dimensions of untreated wounded skin will be used for comparison 3, 6 and 12 months post grafting Secondary Outcome Measures Outcome Measure Measure Description Time Frame Number Participants Positive for NC2 Epitope as a Measure of Duration of Type VII Collagen Production Skin biopsies were obtained to evaluate expression of type VII collagen, NC2 epitope, using immuno-electron microscopy and immuno-fluorescent light microscopy. 3 months, 6 months, 12 months, 24 months post-grafting Other Outcome Measures Outcome Measure Measure Description Time Frame Number of Participants With Presence of Anchoring Fibrils (AF) Skin biopsies were obtained to observe physical development of the anchoring fibrils using electron microscopy 3 months, 6 months, 12 months and 24 months post grafting Keywords Provided by Abeona Therapeutics, Inc gene transfer Additional Relevant MeSH Terms Skin Abnormalities Congenital Abnormalities Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases Skin Diseases, Vesiculobullous Collagen Diseases Connective Tissue Diseases Epidermolysis Bullosa Epidermolysis Bullosa Dystrophica Plan to Share Individual Participant Data (IPD)? Yes IPD Plan Description Results will be submitted to scientific journals for publication and presented at scientific meetings. IPD Sharing Time Frame Study protocol is attached to this submission and will be available per ClinicalTrials.gov timeline. IPD Sharing Supporting Information Type Study Protocol Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Study Documents Provided by Abeona Therapeutics, Inc Study Protocol and Statistical Analysis Plan [ PDF , 0.6MB, 2017-05-13 ] Helpful Links Provided by Abeona Therapeutics, Inc Stanford Dermatology Website: EB Research Update Safety and Wound Outcomes Following Genetically Corrected Autologous Epidermal Grafts in Patients With Recessive Dystrophic Epidermolysis Bullosa.SummaryDifference26%
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