[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645746":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":22,"locations":28,"responsibleParty":102,"collaborators":10,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":10,"eligibilityCriteria":109,"healthyVolunteers":106,"sex":110,"minAge":10,"maxAge":10,"enrollmentInfo":111,"targetDuration":114,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":10,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Abeona Therapeutics, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Patients with RDEB who received pz-cel treatment in the post-marketing setting",null,[12],"Combination Product: Prademagene Zamikeracel",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"COMBINATION_PRODUCT","Prademagene Zamikeracel","ZEVASKYN® (prademagene zamikeracel) is a type of gene therapy made from your own skin cells that is surgically applied to treat wounds in both children and adults who have recessive dystrophic epidermolysis bullosa (RDEB).",[9],[20,21],"EB-101","Pz-cel",[23],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Angela Iheanacho","CONTACT","646-813-7166","aiheanacho@abeonatherapeutics.com",[29,51,68,85],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Lucile Packard Children's Hospital","RECRUITING","Palo Alto","California","94304","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-122.14302,37.44188,{"lat":41,"lon":40},[44,48],{"name":45,"role":25,"phone":46,"phoneExt":10,"email":47},"Thomas Buschbacher","650-313-0354","tbusch@stanford.edu",{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"Joyce Teng","PRINCIPAL_INVESTIGATOR",{"facility":52,"status":31,"city":53,"state":54,"zip":55,"country":35,"countryCode":36,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":38,"coordinates":57},[58,59],-104.83192,39.72943,{"lat":59,"lon":58},[62,66],{"name":63,"role":25,"phone":64,"phoneExt":10,"email":65},"Matthew Brien","7207770802","matthew.brien@childrenscolorado.org",{"name":67,"role":50,"phone":10,"phoneExt":10,"email":10},"Anna Bruckner",{"facility":69,"status":31,"city":70,"state":71,"zip":72,"country":35,"countryCode":36,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Ann & Robert H. Lurie Children's Hospital of Chicago - Department of Dermatology","Chicago","Illinois","60611",{"type":38,"coordinates":74},[75,76],-87.65005,41.85003,{"lat":76,"lon":75},[79,83],{"name":80,"role":25,"phone":81,"phoneExt":10,"email":82},"Alyssa Appleman","3125035927","alyssa.appleman@northwestern.edu",{"name":84,"role":50,"phone":10,"phoneExt":10,"email":10},"Amy Paller",{"facility":86,"status":31,"city":87,"state":88,"zip":89,"country":35,"countryCode":36,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Texas Medical Branch","Galveston","Texas","77555",{"type":38,"coordinates":91},[92,93],-94.7977,29.30135,{"lat":93,"lon":92},[96,100],{"name":97,"role":25,"phone":98,"phoneExt":10,"email":99},"Lindsay Allen","4092662678","listurm@utmb.edu",{"name":101,"role":50,"phone":10,"phoneExt":10,"email":10},"Lindy Ross",{"type":103,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100645746","a-long-term-safety-follow-up-registry-for-patients-who-received-treatment-with-prademagene-zamikeracel-for-recessive-dystrophic-epidermolysis-bullosa-rdeb-in-the-post-marketing-setting-100645746",false,"NCT07700966","A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting","Inclusion Criteria:\n\n* Willing and able to give consent\u002Fassent; if under the age of 18, guardian(s) is(are) willing and able to give consent.\n* Patients who received treatment with prademagene zamikeracel in the post-marketing setting.\n\nExclusion Criteria:\n\n• Inability to properly follow the protocol as determined by the Principal Investigator (PI).","ALL",{"count":112,"type":113},250,"ESTIMATED","15 Years","OBSERVATIONAL","The goal of this observational study is to evaluate the long-term safety and wound healing durability (up to 15 years) for participants with Recessive Dystrophic Epidermolysis Bullosa (RDEB) who were treated with pz-cel. The main questions it aims to answer are:\n\n* The long-term safety profile of pz-cel.\n* The wound healing durability of pz-cel.\n* The occurrence of all malignancies after treatment with pz-cel, regardless of type or location, in individuals who received pz-cel treatment for RDEB in the post-marketing setting.\n\nParticipants will then be followed annually up to 15 years post-treatment. Assessments will occur via remote data collection. If the participants provider determines an office visit is necessary after the first year, some of this data can be collected in person as well. Annual assessments will include, but are not limited to:\n\n* Review of Adverse Events (AEs), Serious Adverse Events (SAEs), hospitalizations, and any evidence of malignancies and potential retroviral infection\n* Wound-healing durability data collection via the modified Caregiver Global Impression of Change for Wound Healing\n* Any changes in concomitant medications and procedures.",[118],"Recessive Dystrophic Epidermolysis Bullosa","2026-07-08",{"date":121,"type":122},"2026-07-14","ACTUAL",{"date":124,"type":122},"2025-07-25",{"date":126,"type":113},"2045-04",{"name":5,"class":6},4]