[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618008":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":112,"collaborators":25,"id":114,"slug":25,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":25,"enrollmentInfo":122,"targetDuration":25,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":137,"whyStopped":25,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"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",[40,57,71,85,99],{"facility":41,"status":25,"city":42,"state":25,"zip":25,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Bordeaux Hospital","Bordeaux","France",{"type":45,"coordinates":46},"Point",[47,48],-0.58046,44.84124,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":25,"email":54},"Marie-Elise TRUCHETET","0556794919","marie-elise.truchetet@chu-bordeaux.fr",{"name":52,"role":56,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":58,"status":25,"city":59,"state":25,"zip":25,"country":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Dijon Hospital","Dijon",{"type":45,"coordinates":61},[62,63],5.01391,47.31344,{"lat":63,"lon":62},[66,70],{"name":67,"role":32,"phone":68,"phoneExt":25,"email":69},"Martin NIVET","04380293432","martin.nivet@chu-dijon.fr",{"name":67,"role":56,"phone":25,"phoneExt":25,"email":25},{"facility":72,"status":25,"city":73,"state":25,"zip":25,"country":43,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Montpellier Hospital","Montpellier",{"type":45,"coordinates":75},[76,77],3.87635,43.61093,{"lat":77,"lon":76},[80,84],{"name":81,"role":32,"phone":82,"phoneExt":25,"email":83},"Alexandre MARIA","0467336733","a-maria@chu-montpellier.fr",{"name":81,"role":56,"phone":25,"phoneExt":25,"email":25},{"facility":86,"status":25,"city":87,"state":25,"zip":25,"country":43,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Nantes Hospital","Nantes",{"type":45,"coordinates":89},[90,91],-1.55336,47.21725,{"lat":91,"lon":90},[94,98],{"name":95,"role":32,"phone":96,"phoneExt":25,"email":97},"Christian AGARD","0240083379","christian.agard@chu-nantes.fr",{"name":95,"role":56,"phone":25,"phoneExt":25,"email":25},{"facility":100,"status":25,"city":101,"state":25,"zip":25,"country":43,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Toulouse Hospital","Toulouse",{"type":45,"coordinates":103},[104,105],1.44367,43.60426,{"lat":105,"lon":104},[108,111],{"name":109,"role":32,"phone":110,"phoneExt":25,"email":34},"Gregory PUGNET","0561322077",{"name":109,"role":56,"phone":25,"phoneExt":25,"email":25},{"type":113,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":123,"type":124},50,"ESTIMATED","INTERVENTIONAL",[127],"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.",[130],"Systemic Scleroderma",[130,132,133,134,135,136],"microstomia","oral health-related quality of life","oral pathology","regenerative medicine","allogenic cultured adipose-derived stromal cells","NOT_YET_RECRUITING","2025-12-23",{"date":140,"type":141},"2026-01-08","ACTUAL",{"date":143,"type":124},"2026-01",{"date":145,"type":124},"2028-07-31",{"name":5,"class":6},5]