[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100302028":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MSC injections","EXPERIMENTAL","Intramuscular injection of mesenchymal stromal cells (50 million allogeneic MSCs in 0.9% NaCl and 10% human serum albumin).",[13],"Drug: Mesenchymal stromal cells",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo injections","PLACEBO_COMPARATOR","Intramuscular injection of placebo (NaCl 0.9% + 10% human serum albumin)",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Mesenchymal stromal cells","8 intramuscular injections at designated sites in the hand\u002Fforearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).",[9],null,{"type":6,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Placebo",[15],[31],{"name":32,"affiliation":5,"role":33},"Marianne Verhaar, MD, PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Femke van Rhijn, MD","CONTACT","0031887557329","f.c.c.brouwer-3@umcutrecht.nl",[41],{"facility":42,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Universitair Medisch Centrum Utrecht","RECRUITING","Utrecht","3584 CX","Netherlands","NL",{"type":49,"coordinates":50},"Point",[51,52],5.12222,52.09083,{"lat":52,"lon":51},[55,56,59],{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"name":57,"role":58,"phone":26,"phoneExt":26,"email":26},"Jaap van Laar, MD, PhD","SUB_INVESTIGATOR",{"name":36,"role":58,"phone":26,"phoneExt":26,"email":26},{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"prof dr. M. C. Verhaar","prof. dr.",[64],{"name":65,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100302028","phase-1-mesenchymal-stromal-cells-as-treatment-for-digital-ulcers-in-systemic-sclerosis-100302028",false,"NCT03211793","Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis","Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial","MANUS","Inclusion Criteria:\n\n* Established diagnosis of SSc according to the 2013 ACR\u002FEULAR criteria\n* At least one active digital ulcer (painful area, \\>2 mm in diameter with visible depth and loss of dermis) refractory to intravenous prostacyclins\n\n  * 'Refractory to prostacyclins' is defined as\n  * Worsening of ulcer(s) within 1 month after prostacyclins iv\n  * No improvement of ulcer(s) after 2 months after prostacyclins iv, as judged by the referring physician\n  * Recurrence of exactly the same ulcer(s) (same location) within 3 months after prostacyclins iv\n* Written informed consent\n\nExclusion Criteria:\n\n* Ulcer with underlying calcinosis (ruled out by X-ray prior to screening\u002Finclusion)\n* History of neoplasm or malignancy in the past 10 years\n* Pregnancy or unwillingness to use adequate contraception during study\n* Serious known concomitant disease with life expectancy \\\u003C1 year\n* Uncontrolled hypertension\n* Uncontrolled acute or chronic infection with systemic symptoms (e.g. fever)\n* Follow-up impossible","ALL","18 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","The MANUS Trial aims to examine the safety, feasibility and potential efficacy of intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers of systemic sclerosis.",[85,86],"Systemic Sclerosis","Digital Ulcer",[88,89,90,91,92,93],"systemic sclerosis","scleroderma","digital ulcer","vasculopathy","mesenchymal stromal cell","mesenchymal stem cell","2025-09-03",{"date":96,"type":97},"2025-09-10","ACTUAL",{"date":99,"type":97},"2021-10-06",{"date":101,"type":78},"2026-11-01",{"name":5,"class":6},1]