[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100389853":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":66,"collaborators":69,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":36,"enrollmentInfo":92,"targetDuration":36,"studyType":95,"phases":96,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":50,"whyStopped":36,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Sir Mortimer B. Davis - Jewish General Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"One infusion of UCMSC","EXPERIMENTAL","Patients receive one intravenous infusion of UCMSC at month 0 and one intravenous infusion of placebo at month 3. Each experimental infusion will consist of 1 million UCMSC\u002Fkg suspended in 50 ml of PlasmaLyte A. Each placebo infusion will consist of a similar volume of PlasmaLyte A.",[13],"Biological: UCMSC",{"label":15,"type":10,"description":16,"interventionNames":17},"Two infusions of UCMSC","Patients receive one intravenous infusion of UCMSC at month 0 and one intravenous infusion of UCMSC at month 3. Each experimental infusion will consist of 1 million UCMSC\u002Fkg suspended in 50 ml of PlasmaLyte A.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo infusions","PLACEBO_COMPARATOR","Patients receive intravenous placebo infusions at months 0 and 3. Each placebo infusion will consist of 50 ml of PlasmaLyte A.",[23],"Other: Placebo",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","UCMSC","Each infusion will consist of 1 million MSC\u002Fkg suspended in 50 mL of PlasmaLyte A.",[9,15],[31],"umbilical cord derived mesenchymal stromal cells",{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Placebo","Each infusion will consist of 50 mL of PlasmaLyte A.",[19],null,[38],{"name":39,"affiliation":5,"role":40},"Marie Hudson, MD","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","514-340-8222","23476","marie.hudson@mcgill.ca",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Sir Mortimer B. Davis Jewish General Hospital","RECRUITING","Montreal","Quebec","H3T 1E2","Canada","CA",{"type":57,"coordinates":58},"Point",[59,60],-73.58781,45.50884,{"lat":60,"lon":59},[63],{"name":64,"role":43,"phone":65,"phoneExt":45,"email":46},"Marie Hudson, MD MPH","1-514-340-8222",{"type":67,"investigatorFullName":39,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Rheumatologist, Jewish General Hospital; Physician-scientist, Lady Davis Institute for Medical Research",[70,72,74,76,78,80],{"name":71,"class":6},"Medical University of South Carolina",{"name":73,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"name":75,"class":6},"Université de Montréal",{"name":77,"class":6},"Assistance Publique - Hôpitaux de Paris",{"name":79,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)",{"name":81,"class":6},"University Paris 7 - Denis Diderot","100389853","phase-1-treatment-with-human-umbilical-cord-derived-mesenchymal-stromal-cells-in-systemic-sclerosis-100389853",false,"NCT04356287","Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis","Phase I\u002FII Randomized Controlled Trial of Umbilical Cord-derived mesenChymAl stRomal cElls in Systemic Sclerosis","CARE-SSc","Inclusion Criteria:\n\n1. SSc according to American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) 2103 classification criteria for systemic sclerosis\n2. Severe disease defined as:\n\n   i) disease duration of 2 years or less with an mRss of \\> 20 and (ESR \\> 25 mm and\u002For hemoglobin \\\u003C 11 g\u002FdL, not explained by other causes than SSc), or ii) mRss \\>15 without any restriction as to disease duration plus at least one major organ involvement as defined by: a) respiratory involvement consisting of lung diffusion capacity for carbon monoxide (DLCO) and\u002For forced vital capacity (FVC) \\\u003C 80% predicted and evidence of interstitial lung disease (chest X-ray and\u002For high resolution computed tomography (HRCT) scan); b) renal involvement consisting of past renal crisis and\u002For stage 2 or 3 chronic kidney disease (glomerular filtration rate between 30-89 mL\u002Fmin) not explained by other causes than SSc; c) cardiac involvement consisting of reversible congestive heart failure, atrial or ventricular rhythm disturbances such as recurrent episodes of atrial fibrillation or flutter, recurrent atrial paroxysmal tachycardia, conduction abnormalities (2nd or 3rd degree atrioventricular block), and\u002For mild to moderate pericardial effusion. All causes of organ involvement should be attributed to SSc.\n3. Inadequate response (determined by patient and physician judgement) or adverse events necessitating discontinuation of standard therapy (usually consisting of methotrexate 25 mg subcutaneous (or as tolerated) per week and\u002For mycophenolate mofetil 2-3 gm\u002Fd (or as tolerated) for at least 3 months\n4. Ineligibility or unwillingness to undergo autologous hematopoietic stem cell transplant\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Pregnancy or unwillingness to use adequate contraception\n3. Life-threatening end-organ damage defined as:\n\n   * FVC \\\u003C 45% and\u002For DLCO (corrected for hemoglobin) \\\u003C 30% predicted;\n   * Left ventricular ejection fraction \\\u003C 40% by cardiac echocardiography;\n   * Pulmonary hypertension with baseline resting systolic pulmonary arterial pressures \\> 50 mmHg by cardiac echocardiography, or mean pulmonary artery pressure \\> 25 mmHg (and pulmonary wedge pressure \\\u003C 15 mmHg) on right heart catheterization;\n   * stage 4 or more chronic kidney disease (glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n4. Liver failure defined as an abnormal transaminase level (aspartate aminotransferase (ASAT), alanine aminotransaminase (ALAT) \\> 3 normal) unless related to activity of the disease\n5. Concurrent neoplasms or myelodysplasia\n6. Uncontrolled hypertension\n7. Uncontrolled acute or chronic infection (HIV, HTLV-1\u002F2 (Human T-lymphotropic virus), hepatitis B surface Ag positive, hepatitis C positive) or high risk thereof\n8. Significant malnutrition with BMI \\\u003C 18 kg\u002Fm2\n9. Severe concomitant psychiatric disorder\n10. Bone marrow insufficiency defined as neutropenia \\\u003C 0.5 x 109 cell\u002FL, thrombocytopenia \\\u003C 30 x 109 cell\u002FL, anemia \\\u003C 8g\u002FdL, CD4+ T lymphopenia \\\u003C 200 x 106 cell\u002FL due to other diseases than SSc (CD4 - cluster of differentiation 4)\n11. History of poor compliance\n12. Concurrent enrolment in any other protocol using an investigational drug\n13. Inability to provide informed consent","ALL","18 Years",{"count":93,"type":94},18,"ESTIMATED","INTERVENTIONAL",[97,98],"PHASE1","PHASE2","The purpose of this study is to test the safety and efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UCMSC) for the treatment of Systemic Sclerosis (SSc).",[101,102],"Sclerosis, Systemic","Mesenchymal Stem Cells",[104,105,106],"Systemic Sclerosis","Umbilical cord-derived mesenchymal stromal cells","Scleroderma, Systemic","2026-01-30",{"date":109,"type":110},"2026-02-03","ACTUAL",{"date":112,"type":110},"2023-01-05",{"date":114,"type":94},"2027-12",{"name":39,"class":6},1]