[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05708677":3,"trial-entities:NCT05708677":110,"trial-summary:NCT05708677":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":15,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":35,"secondary_outcomes":67,"sex":68,"minimum_age":69,"maximum_age":15,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":79,"locations":83,"central_contacts":101,"overall_officials":102,"references":108,"see_also_links":109},"NCT05708677","EB-101-LT-001","A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB","A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)","ENROLLING_BY_INVITATION","2036-08","2026-03","2026-07-17","2021-02-09","Abeona Therapeutics, Inc","INDUSTRY",null,"A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)","This is an open-label, long-term, follow-up study in participants from prior interventional trials involving surgical application of gene-corrected keratinocyte sheets (EB-101) for the treatment of RDEB wound sites. Up to 22 participants will be enrolled in this study, with follow-up through at least 5 years post treatment. Patient-reported outcomes and safety will be assessed throughout the study, and where applicable, compared to Baseline of the preceding interventional EB-101 trial. Upon completion, participants will transfer to an annual monitoring program for additional 10 years of phone visits.",[19],"RDEB",[],"OBSERVATIONAL",[],{"count":24,"type":25},22,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"BIOLOGICAL","EB-101","This is non-interventional and follows patients treated with EB-101",[32],"Long-Term Extension",[34],"pz-cel",[36,40,43,46,49,52,55,58,60,63,65],{"measure":37,"description":38,"timeFrame":39},"Wound Closure","Proportion of RDEB wounds with healing ≥50%, ≥75%, and 100% at all clinic visits up to Month 54 as determined by direct investigator assessment.","5 years",{"measure":41,"description":42,"timeFrame":39},"Pain Severity Scale (Wong-Baker FACES)","Change in pain assessed by Wong-Baker FACES scale at all clinic visits up to Month 54. The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.",{"measure":44,"description":45,"timeFrame":39},"Itch Severity Scale","Longitudinal change of Itch severity scores assessed at all clinic visits up to Week 54. The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.",{"measure":47,"description":48,"timeFrame":39},"Zarit Burden Interview Scale","Longitudinal change of Zarit Burden Interview Short Form (ZBI-12) for caregiver scores related to wound care, assessed at all clinic visits up to Month 54. The minimum score value is 0 and the maximum score value is 4, with the higher scores being the worse outcome.",{"measure":50,"description":51,"timeFrame":39},"Quality of Life in Epidermolysis Bullosa","Quality of Life in Epidermolysis Bullosa (QOLEB) responses will be assessed at all clinic visits up to Month 54.",{"measure":53,"description":54,"timeFrame":39},"Caregiver Global Impression of Change for Pain Scale","Caregiver Global Impression of Change for Pain (CrGI-Pain) scores assessed at all clinic visits up to Month 54. The minimum score value is 1 and the maximum score value is 7, with the higher scores being the worse outcome.",{"measure":56,"description":57,"timeFrame":39},"Wound Infection and Adverse Events","The number of participants and wounds that have an infection or any related adverse event.",{"measure":59,"description":59,"timeFrame":39},"The number of treatment-emergent adverse events.",{"measure":61,"description":62,"timeFrame":39},"Serious Adverse Events","The number of participants and wounds that result in hospitalization (serious adverse event \\[SAE\\]).",{"measure":64,"description":64,"timeFrame":39},"Incidence of squamous cell carcinoma.",{"measure":66,"description":66,"timeFrame":39},"Replication-competent retrovirus (RCR) status",[],"ALL","6 Years",false,{"inclusion":72,"exclusion":76,"raw_text":78},[73,74,75],"Willing and able to give consent\u002Fassent;","If under the age of 18, guardian(s) is\u002Fare willing and able to give consent;","Prior study treatment with EB-101.",[77],"Inability to properly follow protocol as determined by the Principal Investigator","Inclusion Criteria:\n\n* Willing and able to give consent\u002Fassent;\n* If under the age of 18, guardian(s) is\u002Fare willing and able to give consent;\n* Prior study treatment with EB-101.\n\nExclusion Criteria:\n\n* Inability to properly follow protocol as determined by the Principal Investigator",[80,81,82],"CHILD","ADULT","OLDER_ADULT",[84,93],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Stanford University","Redwood City","California","94063","United States",{"lat":91,"lon":92},37.48522,-122.23635,{"facility":94,"city":95,"state":96,"zip":97,"country":89,"geoPoint":98},"University of Massachusetts Medical School","Worcester","Massachusetts","01605",{"lat":99,"lon":100},42.26259,-71.80229,[],[103,106],{"name":104,"affiliation":13,"role":105},"Angela Iheanacho, MS","STUDY_DIRECTOR",{"name":107,"affiliation":13,"role":105},"Sarah Abdelwahab, MD",[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Epidermolysis Bullosa Dystrophica, Autosomal Recessive",[],{"nct_id":4,"found":70,"summary":15,"prompt_version":15}]