[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572335":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":11,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":11,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with BVEC","ACTIVE_COMPARATOR",null,[13],"Drug: BVEC",{"label":15,"type":16,"description":11,"interventionNames":11},"No treatment with BVEC","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","BVEC","The study drug will be administered by home nurse at Subjects home for the participants residing in US. No drug will be applied when at study site. The subjects enrolled in Bari, Italy will not be administered BVEC.",[9],[24],"Beremagene Geperpavec",[26],{"name":27,"affiliation":5,"role":28},"Peter Marinkovich, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Kunju Sridhar","CONTACT","650-721-4902","kunju@stanford.edu",[36,53],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Redwood City","California","94063","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-122.23635,37.48522,{"lat":47,"lon":46},[50,51],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"name":52,"role":28,"phone":11,"phoneExt":11,"email":11},"Peter M Marinkovich, MD",{"facility":54,"status":37,"city":55,"state":11,"zip":11,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Azienda Ospedliero-Universitaia","Bari","Italy","IT",{"type":44,"coordinates":59},[60,61],16.86982,41.12066,{"lat":61,"lon":60},[64,68],{"name":65,"role":32,"phone":66,"phoneExt":11,"email":67},"Lucia Lospalluti, MD","080-5592442","l.lospalluti@gmail.com",{"name":69,"role":28,"phone":11,"phoneExt":11,"email":11},"Lucia Lospalluti",{"type":71,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[73],{"name":74,"class":75},"Epidermolysis Bullosa Research Partnership","OTHER_GOV","100572335","phase-2-impact-of-col7a1-gene-therapy-on-scc-recurrence-in-rdeb-skin-100572335",false,"NCT06731933","Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin","Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin","Inclusion Criteria:\n\n1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations\n2. Presence of biopsy proven squamous cell carcinoma (SCC)\n3. Ability to understand and the willingness to provide written informed consent.\n4. US based participants are willing to use beremagene geperpavec (BVEC)\n5. Subject is 18 years or older\n6. participant willingness to use an effective method of contraception\n\nExclusion Criteria:\n\n1. Inability to travel to site for study visit\n2. Subject is pregnant\n3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.","ALL","18 Years",{"count":86,"type":87},16,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence.\n\nPrevention of SCC's in the RDEB subjects will increase their life span.",[93],"Squamous Cell Carcinoma",[95],"gene therapy","2026-04-15",{"date":98,"type":99},"2026-04-20","ACTUAL",{"date":101,"type":99},"2025-03-28",{"date":103,"type":87},"2027-02",{"name":5,"class":6},2]