[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527228":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":99,"collaborators":103,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":29,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"University of Louisville","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"control group","PLACEBO_COMPARATOR","Four doses of vehicle (Plasma-Lyte A supplemented with 1% HSA) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml\u002Fmin for a total of 60 ml over 30 minutes.",[13],"Biological: umbilical cord-derived mesenchymal stromal cells (UC-MSCs)",{"label":15,"type":16,"description":17,"interventionNames":18},"single-dose group","EXPERIMENTAL","One dose of UC-MSCs (100 x 106 cells) will be infused IV at a rate of 2 ml\u002Fmin for a total of 60 ml over 30 minutes (3.3 million cells\u002Fml\u002Fmin). This will be followed by three IV infusions of placebo (same volume and rate) 2, 4, and 6 months later.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"repeated-dose group","Four doses of UC-MSCs (100 x 106 cells each) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml\u002Fmin for a total of 60 ml over 30 minutes (3.3 million cells\u002Fml\u002Fmin).",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","umbilical cord-derived mesenchymal stromal cells (UC-MSCs)","The study product will consist of 100 million UC-MSCs suspended in a final volume of 60 ml given at a rate of 3.3 million cells\u002Fmin. The product will be infused into vein via intravenous line placed in the arm.",[9,20,15],null,[31],{"name":32,"affiliation":33,"role":34},"Roberto Bolli, MD","University of Louisville School of Medicine","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":29,"email":39},"CONTACT","502-608-5426","rbolli@louisville.edu",{"name":41,"role":37,"phone":42,"phoneExt":29,"email":43},"Michelle Unseld, RN","502-540-3423","michelle.unseld@louisville.edu",[45,67,81],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Miami Miller School of Medicine","RECRUITING","Miami","Florida","33136","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-80.19366,25.77427,{"lat":57,"lon":56},[60,64],{"name":61,"role":37,"phone":62,"phoneExt":29,"email":63},"Joshua Hare, MD","305-243-1152","JHare@med.miami.edu",{"name":65,"role":37,"phone":62,"phoneExt":29,"email":66},"Ana Garzon","amg9460@med.miami.edu",{"facility":68,"status":47,"city":69,"state":70,"zip":71,"country":51,"countryCode":52,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"University of Louisville School of Medicine, Institute of Molecular Cardiology","Louisville","Kentucky","40202",{"type":54,"coordinates":73},[74,75],-85.75941,38.25424,{"lat":75,"lon":74},[78,79,80],{"name":32,"role":37,"phone":38,"phoneExt":29,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":29,"email":43},{"name":32,"role":34,"phone":29,"phoneExt":29,"email":29},{"facility":82,"status":47,"city":83,"state":84,"zip":85,"country":51,"countryCode":52,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"The Texas Heart Institute Houston Texas","Houston","Texas","77030",{"type":54,"coordinates":87},[88,89],-95.36327,29.76328,{"lat":89,"lon":88},[92,96],{"name":93,"role":37,"phone":94,"phoneExt":29,"email":95},"Emerson Perin, MD","832-355-9173","eperin@texasheart.org",{"name":97,"role":37,"phone":94,"phoneExt":29,"email":98},"Nicole Piece","npiece@texasheart.org",{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Roberto Bolli","Endowed Chair, M.D.",[104,106,108],{"name":105,"class":6},"University of Miami",{"name":107,"class":6},"University of Texas",{"name":109,"class":110},"United States Department of Defense","FED","100527228","phase-2-single-or-repeated-intravenous-administration-of-umbilical-cord-mesenchymal-stromal-cells-in-ischemic-cardiomyopathy-100527228",false,"NCT06145035","Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy","University of Louisville - 18642 \u002F CATO Study, Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy","CATO","Inclusion Criteria:\n\n1. Be ≥ 21 and ≤ 85 years of age.\n2. Have documented CAD (\\> 70% lesion in at least 1 epicardial vessel) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF.\n3. Have a \"detectable\" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by MRI.\n4. Have an EF ≤ 40% by MRI.\n5. Be receiving guideline driven medical therapy for HF (beta blockers, diuretics, ACE inhibitors or ARBs, or ARNIs, aldosterone antagonists, hydralazine isosorbide, sodium-glucose transporter 2 inhibitors) ) at stable, maximally tolerated doses for ≥ 1 month prior to consent. \"Stable\" is defined as stable dose with no changes for 30 days after last dose adjustment. For beta blockade \"stable\" is defined as no greater than a 50% reduction in dose or no more than a 100% increase in dose.\n6. Have NYHA class I, II or III symptoms of HF (see Appendix A)\n7. If a female of childbearing potential, be willing to use one form of birth control for the duration of the study and undergo a serum pregnancy test at baseline and within 36 hours prior to infusion\n\nExclusion Criteria:\n\n1. Indication for standard of care surgery (including valve surgery, placement of left ventricular assist device, or imminent heart transplantation), coronary artery bypass grafting (CABG) procedure, and\u002For percutaneous coronary intervention (PCI) for the treatment of ischemic and\u002For valvular heart disease. Subjects who require or undergo PCI should undergo these procedures a minimum of 3 months in advance of randomization. Subjects who require or undergo CABG should undergo these procedures a minimum of 3 months in advance of randomization. In addition, subjects who develop a need for revascularization following enrollment should undergo revascularization without delay. Indication for imminent heart transplantation is defined as a high likelihood of transplant prior to collection of the 12 month study endpoint. Candidates cannot be UNOS 1A or 1B, and they must have documented a low probability of being transplanted.\n2. Severe valvular (any valve) insufficiency and\u002For regurgitation within 12 months of consent\n3. History of ischemic or hemorrhagic stroke within 90 days of consent\n4. Presence of a pacemaker and\u002For implantable cardiac device (ICD) generator with any of the following limitations\u002Fconditions:\n\n   * manufactured before the year 2000\n   * leads implanted \\\u003C 6 weeks prior to consent\n   * non transvenous epicardial or abandoned leads\n   * subcutaneous ICDs (if not MRI compatible)\n   * leadless pacemakers\n   * any other condition that, in the judgment of device trained staff, would deem an MRI contraindicated\n5. Pacemaker dependence with an ICD (Note: pacemaker dependent candidates without an ICD are not excluded)\n6. A cardiac resynchronization therapy (CRT) device implanted less than 3 months prior to consent.\n7. Other MRI contraindications (e.g. patient body habitus incompatible with MRI)\n8. An appropriate ICD firing or anti tachycardia pacing (ATP) for ventricular fibrillation or ventricular tachycardia within 30 days of consent\n9. Ventricular tachycardia ≥ 20 consecutive beats without an ICD within 3 months of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent\n10. Evidence of active myocarditis\n11. Baseline glomerular filtration rate (eGFR) \\\u003C 35 ml\u002Fmin\u002F1.73m2\n12. Blood glucose levels (HbA1c) \\>10%\n13. Hematologic abnormality evidenced by hematocrit \\\u003C 25%, white blood cell \\\u003C 2,500\u002Ful or platelet count \\\u003C 100,000\u002Ful\n14. Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3 times the ULN.\n15. HIV and\u002For active HBV or HCV\n16. Known history of anaphylactic reaction to penicillin or streptomycin\n17. Received gene or cell based therapy from any source within the previous 12 months.\n18. History of malignancy within 2 years (i.e., subjects with prior malignancy must be disease free for 2 years), excluding basal cell carcinoma and cervical carcinoma in situ which have been definitively treated.\n19. Condition that limits lifespan to \\\u003C 1 year\n20. History of drug abuse (illegal \"street\" drugs except marijuana, or prescription medications not being used appropriately for a pre-existing medical condition) or alcohol abuse (≥ 5 drinks\u002Fday for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 12 months.\n21. Participation in an investigational therapeutic or device trial within 30 days of consent\n22. Cognitive or language barriers that prohibit obtaining informed consent or any study elements\n23. Pregnancy or lactation or plans to become pregnant in the next 12 months.\n24. Any other condition that, in the judgment of the Investigator or Sponsor, would impair enrollment, study product administration, or follow up.","ALL","21 Years","85 Years",{"count":123,"type":124},60,"ESTIMATED","INTERVENTIONAL",[127],"PHASE2","This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs, stem cells), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).",[130],"Ischemic Heart Disease",[132,133],"ischemic cardiopathy","UC-MSCs","2026-05-08",{"date":136,"type":137},"2026-05-13","ACTUAL",{"date":139,"type":137},"2024-03-04",{"date":141,"type":124},"2028-09-01",{"name":101,"class":6},3]