[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618008":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":113,"collaborators":25,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":25,"enrollmentInfo":124,"targetDuration":25,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":139,"whyStopped":25,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AdMSC","EXPERIMENTAL","Patients will be standard of care (physiotherapy and daily self-administered exercises) and receive allogeneic AdMSC injection in the perioral (lips) region.",[13],"Drug: AdMSC",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients will be standard of care (physiotherapy and daily self-administered exercises) and receive placebo injections in the perioral (lips) region",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","At day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"At day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Gregory PUGNET, MD, PHD","CONTACT","0561323954","pugnet.g@chu-toulouse.fr",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Charline DAGUZAN","0561778490","daguzan.c@chu-toulouse.fr",[40,58,72,86,100],{"facility":41,"status":25,"city":42,"state":25,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Bordeaux Hospital","Bordeaux","France","FR",{"type":46,"coordinates":47},"Point",[48,49],-0.58046,44.84124,{"lat":49,"lon":48},[52,56],{"name":53,"role":32,"phone":54,"phoneExt":25,"email":55},"Marie-Elise TRUCHETET","0556794919","marie-elise.truchetet@chu-bordeaux.fr",{"name":53,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":59,"status":25,"city":60,"state":25,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Dijon Hospital","Dijon",{"type":46,"coordinates":62},[63,64],5.01391,47.31344,{"lat":64,"lon":63},[67,71],{"name":68,"role":32,"phone":69,"phoneExt":25,"email":70},"Martin NIVET","04380293432","martin.nivet@chu-dijon.fr",{"name":68,"role":57,"phone":25,"phoneExt":25,"email":25},{"facility":73,"status":25,"city":74,"state":25,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Montpellier Hospital","Montpellier",{"type":46,"coordinates":76},[77,78],3.87635,43.61093,{"lat":78,"lon":77},[81,85],{"name":82,"role":32,"phone":83,"phoneExt":25,"email":84},"Alexandre MARIA","0467336733","a-maria@chu-montpellier.fr",{"name":82,"role":57,"phone":25,"phoneExt":25,"email":25},{"facility":87,"status":25,"city":88,"state":25,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Nantes Hospital","Nantes",{"type":46,"coordinates":90},[91,92],-1.55336,47.21725,{"lat":92,"lon":91},[95,99],{"name":96,"role":32,"phone":97,"phoneExt":25,"email":98},"Christian AGARD","0240083379","christian.agard@chu-nantes.fr",{"name":96,"role":57,"phone":25,"phoneExt":25,"email":25},{"facility":101,"status":25,"city":102,"state":25,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Toulouse Hospital","Toulouse",{"type":46,"coordinates":104},[105,106],1.44367,43.60426,{"lat":106,"lon":105},[109,112],{"name":110,"role":32,"phone":111,"phoneExt":25,"email":34},"Gregory PUGNET","0561322077",{"name":110,"role":57,"phone":25,"phoneExt":25,"email":25},{"type":114,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100618008","phase-2-efficacy-and-safety-of-allogenic-cultured-adipose-derived-mesenchymal-stromal-cell-injections-on-mouth-fibrosis-and-handicap-in-patients-with-systemic-scleroderma-100618008",false,"NCT07326033","Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma","A-MUSE","Inclusion Criteria:\n\n* Male or female patient ≥18 years of age,\n* Patient with systemic scleroderma according to the 2013 ACR\u002FEULAR classification criteria,\n* Mouth Handicap in Systemic Sclerosis Scale (MHISS) score more than or equal to 20 (0-48),\n* Rodnan skin score on the face more than or equal to 1,\n* Maximal mouth opening of less than 40 mm (distance between the dental arches)\n* Patient must have provided written informed consent prior to enrolment,\n* Patient must be able to understand their requirements of participating in the protocol.\n* Patient affiliated to a social security system.\n\nExclusion Criteria:\n\n* Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months,\n* Injection of botulinum toxin within 4 weeks prior to \"inclusion visit\",\n* Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year,\n* Local active labial herpes virus within 1 week prior to \"inclusion visit\",\n* Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national MATHEC-SFGMTC guidelines),\n* History of cancer in the last five years, except for successfully excised basal cell\u002Fsquamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had a successful tumor resection or radiation or chemotherapy more than 5 years prior to inclusion and no recurrence, may be enrolled in the study,\n* Radio- or chemotherapy in progress,\n* Females who are pregnant or breastfeeding or plan to be or do so during the course of this study,\n* Women of childbearing potential (WOCBP) who are sexually active and unwilling to use an adequate birth control method,\n* Vulnerable patient (persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research) according to article L1121-6 of the Public Health Code","ALL","18 Years",{"count":125,"type":126},50,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","Orofacial manifestations and microstomia are a frequent complication in systemic sclerosis (SSc) with a major impact on oral hygiene, dental care and quality of life. Peri-oral injection of allogeneic cultured adipose-derived stromal cells constitutes a promising approach to treat scleroderma-induced mouth fibrosis where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of perioral injection of allogeneic cultured adipose-derived stromal cells (AdMSC) versus placebo to improve oro-facial fibrosis in patients with systemic sclerosis.",[132],"Systemic Scleroderma",[132,134,135,136,137,138],"microstomia","oral health-related quality of life","oral pathology","regenerative medicine","allogenic cultured adipose-derived stromal cells","NOT_YET_RECRUITING","2025-12-23",{"date":142,"type":143},"2026-01-08","ACTUAL",{"date":145,"type":126},"2026-01",{"date":147,"type":126},"2028-07-31",{"name":5,"class":6},5]