[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513730":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":39,"responsibleParty":68,"collaborators":70,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":25,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":105,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs)","EXPERIMENTAL","Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells",[13],"Biological: Allogeneic umbilical cord-derived human mesenchymal stromal cells",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Intravenous infusion of placebo, with excipients",[19],"Other: Placebo",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Allogeneic umbilical cord-derived human mesenchymal stromal cells",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"Lauralyn McIntyre, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Josee Champagne","CONTACT","613-737-8899","73836","UCCISS@ohri.ca",[40,58],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The Ottawa Hospital (General Campus)","RECRUITING","Ottawa","Ontario","K1H 8L6","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-75.69812,45.41117,{"lat":52,"lon":51},[55,57],{"name":56,"role":35,"phone":25,"phoneExt":25,"email":38},"Irene Watpool, RN",{"name":30,"role":31,"phone":25,"phoneExt":25,"email":25},{"facility":59,"status":42,"city":43,"state":44,"zip":60,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"The Ottawa Hospital (Civic Campus)","K1Y 4E9",{"type":49,"coordinates":62},[51,52],{"lat":52,"lon":51},[65,67],{"name":66,"role":35,"phone":25,"phoneExt":25,"email":38},"Rebecca Porteous, RN",{"name":30,"role":31,"phone":25,"phoneExt":25,"email":25},{"type":69,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[71,74,76,78],{"name":72,"class":73},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":75,"class":6},"Stem Cell Network",{"name":77,"class":6},"Canadian Critical Care Trials Group",{"name":79,"class":6},"Technische Universität Dresden","100513730","phase-2-umbilical-mesenchymal-stromal-cells-as-cellular-immunotherapy-for-septic-shock-100513730",false,"NCT05969275","Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock","Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock: A Multi-Center, Double Blind, Phase II Randomized Controlled Trial","UC-CISSII","Inclusion Criteria:\n\nA participant must meet all the following inclusion criteria at time of randomization to be eligible:\n\n1. At least 18 years of age AND\n2. Requirement for admission to the intensive care unit AND\n3. Index admission to the intensive care unit AND\n4. Cardiovascular organ failure for at least 1 consecutive hour defined by the requirement of at least 5 mcg\u002Fmin of norepinephrine or 100 mcg\u002Fmin of phenylephrine or 0.03 U\u002Fmin vasopressin AND\n5. Clinician impression that cardiovascular organ failure is related to infection AND\n6. There is at least 1 other acute organ failure according to modified individual Sequential Organ Failure Assessment Scores within 24 hours of meeting Cardiovascular organ failure defined by:\n\n   1. Respiratory failure: invasive or non-invasive mechanical ventilation with a positive end expiratory pressure (PEEP) \\>\u002F= 5 cm H2O and a partial pressure of oxygen\u002Ffractional inspired oxygen concentration (P\u002FF ratio \\\u003C\u002F= 200), OR high-flow nasal canula oxygen therapy (minimum total flow rate of 30 lpm and 40% FiO2); OR\n   2. Hematological failure: platelet count of \\\u003C\u002F= 100 X 10\\^9\u002FL OR\n   3. Acute kidney injury: acute renal insufficiency with a creatinine of \\>\u002F= 200 umol\u002FL, or the requirement for new renal replacement therapy, or for participants with known chronic renal failure but not on dialysis, a 50% increase in their baseline creatinine concentration OR\n   4. Organ hypoperfusion: a lactate \\>\u002F= 4 mmol\u002FL\n\nAcute organ failures that meet eligibility criteria must not have been present for greater than 48 hours prior to meeting the eligibility criteria.\n\nExclusion Criteria:\n\nPatients will be excluded if they have at least one of the following at time of randomization:\n\n1. Another form of shock (cardiogenic, hypovolemic, obstructive) OR\n2. History of known chronic pulmonary hypertension with a WHO functional class of IV OR\n3. History of severe chronic pulmonary disease requiring home oxygen OR\n4. History of severe chronic cardiac disease including congestive heart failure or valvular dysfunction with a New York Heart Association Functional class IV or severe chronic ischemic heart disease with a Canadian Cardiovascular Society angina class score IV OR\n5. History of severe chronic liver disease (Child-Pugh Class C or model for end stage liver disease (MELD) Score \\>= 15) OR\n6. Malignancy in previous 1 year (excluding resolved non-melanoma skin cancer) OR\n7. Treating physician impression that death is imminent within the 12 hours after meeting eligibility criteria OR\n8. Pregnant or lactating OR\n9. Family or patient not committed to aggressive care","ALL","18 Years",{"count":91,"type":92},296,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).",[98,99,100,101,102,103,104],"Septic Shock","Sepsis","Pathologic Processes","Shock","Systemic Inflammatory Response Syndrome","Inflammation","Infections",[106,107,108,109,110,111,112,99,98],"Mesenchymal Stem Cells","Mesenchymal Stromal Cells","Randomized Controlled Trial","Cryopreserved","Allogeneic","Umbilical Cord","Phase II","2024-12-04",{"date":115,"type":116},"2024-12-05","ACTUAL",{"date":118,"type":116},"2024-02-14",{"date":120,"type":92},"2027-03-31",{"name":5,"class":6},2]