[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lyell-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lyell-syndrome":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100417093","phase-1-lyell-syndrome-mesenchymal-stromal-cells-treatment-100417093",false,"NCT04711200","LYell SYndrome MEsenchymal Stromal Cells Treatment","Mesenchymal Stromal Cells Treatment in Lyell Syndrome: A Pilot Phase 1-2 Open Trial","LYSYME","Inclusion Criteria:\n\n* Patients ≥ 18 and ≤ 75 years-old\n* Admission ≤ 10 days after the index date (date of the first symptoms of the disease)\n* Patient with confirmed SJS-TEN diagnosis hospitalized in the department of Dermatology or intensive care medicine\n* At least 10 % of detachable-detached body surface area at any time during the first 10 days after the index date (date of the first symptoms of the disease)\n* Who, after the nature of the study has been explained to them or a support person (if applicable), and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* History of malignant disease within the past ten years and or presence of metastasis\n* Positive serology for HIV\n* Active infection for hepatitis B or C\n* Detection of Coronavirus SARS CoV-2 RNA on admission (positive RT-PCR), if performed in the usual care\n* Decompensated cardiac failure\n* Uncontrolled epilepsia\n* Previous history of allogenic bone marrow transplantation\n* Participation in other interventional drug research Patient deprived of liberty by a judicial or administrative decision or under the protection of justice\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the research protocol and follow-up schedule\n* Patient under tutorship or curatorship\n* Patient under psychiatric care according to art. L1121-6 CSP","ALL","18 Years","75 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare severe cutaneous adverse reactions (SCARs) to drugs.\n\nTo date, no curative drug has demonstrated with a good level of evidence its ability to promote SJS and TEN healing and could contribute to earlier reepithelialisation. Mesenchymal stroma cells (MSCs) therapy represents a new therapeutic approach. eg, in patients with cardiovascular diseases, neurological diseases, renal transplantation, lung diseases as acute respiratory distress syndrome.\n\nRecently, MSCs have been proposed in both burn wound healing with a significantly decrease of the unhealed burn area and in cutaneous radiation.\n\nMoreover, MSCs have immunomodulation properties potentially effective in refractory acute and chronic graft versus host disease (GVHD) by improving thymic function and induction of Tregs. Indeed, MSCs are able to migrate to inflamed tissues after stimulation by pro-inflammatory cytokines and to modulate the local inflammatory reactions. MSCs have also demonstrated their ability to promote tissue remodelling, angiogenesis and immunomodulation through either differentiation or secretion of several growth factors such as VEGF, basic FGF and various cytokines.\n\nTherefore, combining their immunomodulation effect and secretion of soluble factors involved in wound repair, MSCs might be valuable as a cell therapy strategy for promoting cutaneous healing in SJS-TEN syndrome and subsequently decrease the morbi-mortality.",[29,30,31,32,33,34],"Epidermal Necrolysis","Lyell Syndrome","Toxic Epidermal Necrolysis","Overlap Syndrome","Mesenchymal Stromal Cells","Adipose Derived Stromal Cells",[36,37,38,39,40,41],"Epidermal necrolysis","Lyell syndrome","toxic epidermal necrolysis","Overlap syndrome","Mesenchymal stromal cells","Adipose derived stromal cells","RECRUITING","2025-07-29",{"date":45,"type":46},"2025-08-01","ACTUAL",{"date":48,"type":46},"2024-04-15",{"date":50,"type":22},"2027-04",{"name":52,"class":53},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":74,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":54},"100336346","drug-reactions-sampling-collectiontoxidermies-100336346","NCT03659227","Drug Reactions Sampling (COLLECTIONTOXIDERMIES)","Adverse Cutaneous Drug Reactions Collection of Clinical Data and Biological Samples","Inclusion Criteria:\n\n* Patient ≥ 18 y-old\n* Severe cutaneous drug reaction (AGEP, DRESS, SJS\u002FTEN, generalized bullous fixed drug eruption), drug-induced IgA bullous dermatosis, maculopapular exanthema, erythema multiforme\n* Signed consent\n* Social security affiliation\n\nExclusion Criteria:\n\n* Patients law protection",{"count":63,"type":22},500,"OBSERVATIONAL","Intro: Dermatology department of Henri Mondor Hospital (Creteil, France), is a reference center for toxic bullous diseases and severe cutaneous drug reactions (Stevens-Johnson syndrome (SJS), Lyell syndrome (toxic epidermal necrolysis (TEN)), generalized bullous fixed drug reactions, AGEP, DRESS, drug induced immunoglobulin A (IgA) bullous dermatosis, and erythema multiforme). In order to conduct clinical and biological research studies in drug reactions, it is necessary for the investigator's department to implement a collection of clinical data and biological samples.\n\nHypothesis\u002FObjective: To collect clinical data and cutaneous and biological samples for immunological, biological and genetic studies to improve knowledge about pathophysiology of drug reactions.\n\nMethod: The following samples will be performed in addition to the routine practice samples: one skin punch biopsy (6mm); 43 mL of blood; blister fluid aspiration; oral and nose mucous membrane and skin eSWABs, stool samples.\n\nThese samples will be stored in a dedicated biological sampling department (\"Platform of biological resources\").\n\nConclusion: The implementation of this collection should allow us to conduct pathophysiological studies about drug reactions.",[67,30,68,69,70,71,72,73],"Stevens-Johnson Syndrome","Drug Reactions","AGEP","DRESS","Bullous Dermatosis Caused by Drug Treatment (Disorder)","Maculopapular Exanthem","Erythema Multiforme",[75,76,77,30,78,69,70,79,80,81,82,83],"Drug reactions","severe cutaneous adverse reactions (SCARs","Stevens-Johnson syndrome","(generalized bullous) fixed drug reaction","drug induced IgA bullous dermatosis","maculopapular exanthema","erythema multiforme","sampling","collection","2022-05-02",{"date":86,"type":46},"2022-05-03",{"date":88,"type":46},"2018-09-26",{"date":90,"type":22},"2028-09-25",{"name":52,"class":53}]