[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642702":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":46,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":73,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with Systemic Sclerosis and Healthy Controls","EXPERIMENTAL","Participants undergo blood sample collection for generation of induced pluripotent stem cells (iPSCs) and in vitro cellular and tissue modeling.",[13],"Procedure: Blood Sample Collection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Blood Sample Collection","Collection of approximately 28 mL of blood from each participant to generate induced pluripotent stem cell (iPSC) lines for in vitro cellular and tissue modeling analyses.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"ARNAUD BOURDIN, MD","STUDY_DIRECTOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","04 67 33 61 26","a-bourdin@chu-montpellier.fr",[31],{"facility":32,"status":20,"city":33,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"University hospital Montpellier","Montpellier","France","FR",{"type":37,"coordinates":38},"Point",[39,40],3.87635,43.61093,{"lat":40,"lon":39},[43],{"name":23,"role":27,"phone":44,"phoneExt":45,"email":29},"04 67 33 6126","33",{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100642702","tissue-modeling-in-systemic-sclerosis-using-induced-pluripotent-stem-cells-ipscs-100642702",false,"NCT07650565","Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)","hiPSSS","Inclusion Criteria:\n\n* Age between 18 and 85 years\n* Diagnostic criteria for the three groups:\n\n  \\> Severe SSc group:\n* Diagnosis of diffuse\u002Fsevere systemic sclerosis by a physician for at least 12 months based on recommendations (according to ACR criteria)\n* Known positivity of autoimmunity directed against Scl-70\n\n  \\> Localized\u002Fnon-complicated SSc group:\n* Diagnosis of systemic sclerosis by a physician for at least 12 months based on recommendations (according to ACR criteria)\n* Documentation of the absence of major vital organ involvement\n* Negative anti-Scl-70 autoantibodies but presence of other systemic sclerosis-related autoantibodies\n\n  \\> Healthy subjects group:\n* First-degree relative of a patient recruited in one of the systemic sclerosis groups (father, mother, brother, sister, adult child)\n* Absence of systemic autoimmune diseases\n\nExclusion Criteria:\n\n* Other diseases that may affect erythroid progenitor cells (non-exhaustive: active cancer, hematological malignancy, chemotherapy targeting DNA)\n* Patient in an exclusion period determined by another protocol\n* Protected populations according to French public health law (pregnant or breastfeeding women; individuals deprived of liberty by judicial or administrative decision; adults under legal protection (any form of guardianship))\n* Absence of informed consent\n* Not affiliated with a national health insurance system",true,"ALL","18 Years","85 Years",{"count":60,"type":61},16,"ESTIMATED","INTERVENTIONAL",[64],"NA","The objective of the study is to establish an in vitro model using iPSCs to test the hypotheses developed.\n\nThe primary objective is to generate, via the SAFE-IPS platform, 8 iPSC lines derived from blood samples taken from:\n\n* Two patients with severe\u002Fdiffuse SSc with multi-organ involvement (with anti-SCl-70 autoantibodies)\n* Two of their healthy close relatives\n* Two patients with uncomplicated SSc with localized involvement (with non-SCl-70 autoantibodies)\n* Two of their healthy close relatives\n\nThese 8 cell lines will be differentiated by several teams at the FHU REGENHAB into:\n\n* Immune cells (monocytes\u002Fmacrophages, neutrophils, dendritic cells, B\u002FT lymphocytes)\n* Mesenchymal stromal cells\n* Myocardial cells\n* Skin cells (fibroblasts)\n* Synovial cells\n* Bronchial cells\n* Endothelial cells\n\nThis project aims to map cellular and tissue heterogeneity using iPSC lines obtained from patients with both severe and mild SSc, employing single-cell RNA-seq under various pathological conditions, with and without autologous (or even heterologous) autoimmune stimulation. For example, the percentages of different cell types comprising a tissue in these various situations will be calculated. Comparisons will be made with control groups using healthy iPSC lines by recruiting healthy subjects with the same genetic profile and gender as the patients.",[67],"Systemic Sclerosis (SSc)",[69,70,71,72],"Systemic Sclerosis","Induced Pluripotent Stem Cells","Autoimmune Disease","Tissue Modeling","NOT_YET_RECRUITING","2026-06-11",{"date":76,"type":77},"2026-06-16","ACTUAL",{"date":79,"type":61},"2026-09",{"date":81,"type":61},"2028-03",{"name":5,"class":6},1]