[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529713":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":60,"collaborators":10,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"EBDR patients",null,[12],"Other: Sampling",{"label":14,"type":10,"description":10,"interventionNames":15},"Healthy control",[12],[17],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"Sampling","Blood sampling Skin biopsy Collection of soiled bandages",[9,14],[22],{"name":23,"affiliation":24,"role":25},"Reem Al-Daccak, Dr","Institut National de la Santé Et de la Recherche Médicale, France","STUDY_DIRECTOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Emmannuelle Bourrat, Pr","CONTACT","+33142499090","emmanuelle.bourrat@aphp.fr",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Jérôme Lambert, Pr","+33142499742","jerome.lambert@u-paris.fr",[37,52],{"facility":38,"status":39,"city":40,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hopital Saint Louis - Service de chirurgie plastique reconstructrice et esthétique et traitement chirurgical des brûlés","RECRUITING","Paris","France","FR",{"type":44,"coordinates":45},"Point",[46,47],2.3488,48.85341,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":10,"phoneExt":10,"email":10},"Maurice Mimoun, MD",{"facility":53,"status":39,"city":40,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Hopital Saint Louis - service dermatologie",{"type":44,"coordinates":55},[46,47],{"lat":47,"lon":46},[58],{"name":59,"role":29,"phone":10,"phoneExt":10,"email":10},"Emmanuelle Bourrat, MD",{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100529713","study-of-the-blood-and-skin-immunological-profile-of-patients-with-recessive-dystrophic-epidermolysis-bullosa-in-vivo-analysis-and-the-impact-of-placental-stem-cells-in-vitro-100529713",false,"NCT06177353","Study of the Blood and Skin Immunological Profile of Patients With Recessive Dystrophic Epidermolysis Bullosa: in Vivo Analysis and the Impact of Placental Stem Cells in Vitro","Etude du Profil Immunologique Sanguin et cutané Des Patients Atteints d'épidermolyse Bulleuse Dystrophique récessive : Analyses in Vivo et Impact Des Cellules Souches Placentaires in Vitro","ISTRADEB","Inclusion Criteria:\n\nEBDR patients :\n\n* Patients aged 18 to 80 years old\n* Clinically, histologically, and\u002For genetically confirmed intermediate, reversed or generalized, moderate to severe EBDR\n\nHealthy controls :\n\n* Adults aged 18 to 80 years old\n* PBMC healthy donors: subjects who have donated blood to the EFS according to the indication criteria who have consented to the use of their samples for research purposes.\n* Healthy skin biopsy donors: subjects undergoing abdominoplasty scheduled in plastic surgery and who have given their consent for the collection of a skin biopsy from post-operative abdominoplasty skin remnants.\n* Healthy donors of bandages soiled with exudates from cutaneous wounds: subject consulting a plastic surgery department as part of their usual post-operative follow-up, who have given their consent for the collection of one of their dressings during their usual during their usual renewal.\n\nFor all subjects :\n\n* Free, informed, written consent, signed by the person and the investigator no later than the day of inclusion and before any examination carried out as part of the study.\n* Person affiliated or benefiting from a social security scheme\n\nExclusion Criteria:\n\nEBDR patients :\n\n* EBH with no definite diagnosis or other than EBDR intermediate, reversed or generalized\n* Systemic anti-inflammatory or immunosuppressive therapy for less than one month\n* Refusal of skin biopsy\n\nHealthy controls :\n\n* Acute or chronic systemic or cutaneous inflammatory disease at the time of sampling\n* Current immunosuppressive anti-inflammatory treatment in the month prior to sampling\n\nFor all subjects:\n\n* Persons under guardianship or curatorship, or deprived of their liberty by judicial or administrative decision\n* Patients receiving State Medical Aid\n* Pregnant or breast-feeding women",true,"ALL","18 Years","80 Years",{"count":75,"type":76},30,"ESTIMATED","OBSERVATIONAL","Patients with recessive dystrophic epidermolysis bullosa (RDEB) suffer from acute and chronic post-bullous wounds along with impaired skin healing. These issues are attributed not only to mucocutaneous fragility and abnormal healing directly related to quantitative and\u002For qualitative constitutional abnormalities of collagen VII but also to a contingent cutaneous and systemic inflammatory component. This inflammatory aspect contributes to the perpetuation of skin lesions and delayed healing. Our primary objective is to define the systemic immunological\u002Finflammatory signature of patients with RDEB with an aim to develop a strategy that involves using stem cells with high immunomodulatory\u002Fanti-inflammatory capacity such as allogeneic placental stem cells (WJ-MSCs and trophoblasts).",[80],"Epidermolysis Bullosa Dystrophica","2024-07-15",{"date":83,"type":84},"2024-07-17","ACTUAL",{"date":86,"type":84},"2024-04-15",{"date":88,"type":76},"2025-04-15",{"name":5,"class":6},2]