[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100282907":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":46,"centralContacts":50,"locations":55,"responsibleParty":73,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":37,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":37,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":37,"overallStatus":58,"whyStopped":37,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (hMSCs IV)","EXPERIMENTAL","Patients receive hMSCs IV over 10-20 minutes on days 1, 14, 21, and 28 and standard of care treatment for heart failure in the absence of disease progression or unacceptable toxicity.",[13,14,15],"Other: Best Practice","Other: Laboratory Biomarker Analysis","Drug: Mesenchymal Stem Cell Transplantation",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm II (hMSCs transendocardially)","Patients receive hMSCs transendocardially for a total of 15 injections and standard of care treatment for heart failure in the absence of disease progression or unacceptable toxicity.",[13,14,15],{"label":21,"type":22,"description":23,"interventionNames":24},"Arm III (standard of care)","ACTIVE_COMPARATOR","Patients receive standard of care treatment for heart failure.",[13,14],[26,33,38,43],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Best Practice","Given standard of care",[9,17,21],[31,32],"standard of care","standard therapy",{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Laboratory Biomarker Analysis","Correlative studies",[9,17,21],null,{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":37},"DRUG","Mesenchymal Stem Cell Transplantation","Given IV",[9],{"type":39,"name":40,"description":44,"armGroupLabels":45,"otherNames":37},"Given transendocardially",[17],[47],{"name":48,"affiliation":5,"role":49},"Amanda Olson, MD","PRINCIPAL_INVESTIGATOR",[51],{"name":48,"role":52,"phone":53,"phoneExt":37,"email":54},"CONTACT","713-745-3055","alolson@mdanderson.org",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-95.36327,29.76328,{"lat":68,"lon":67},[71,72],{"name":48,"role":52,"phone":53,"phoneExt":37,"email":54},{"name":48,"role":49,"phone":37,"phoneExt":37,"email":37},{"type":74,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[76],{"name":77,"class":78},"National Cancer Institute (NCI)","NIH","100282907","phase-1-donor-bone-marrow-derived-mesenchymal-stem-cells-in-controlling-heart-failure-in-patients-with-cardiomyopathy-caused-by-anthracyclines-100282907",false,"NCT02962661","Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines","Randomized 3-Arm Trial With Standard of Care Alone vs Either Intravenous Infusion or Transendocardial Injection of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) Plus Standard of Care in Patients With Anthracycline-Associated Cardiomyopathy","Inclusion Criteria:\n\n1. Patients with LVEF \\\u003C\u002F= 40% documented from treatment with anthracyclines for any malignancy at any dose at any time without evidence of other causes of cardiomyopathy.\n2. Age \\>\u002F= 18 and \\\u003C\u002F= 90 years of age. English and non-English speaking patients are eligible.\n3. Documented NYHA class I, II and III.\n4. For patients who have received trastuzumab: Persistent LV dysfunction must be present 90 days after discontinuation of trastuzumab.\n5. Able to perform 6 minute walk test.\n6. Been treated with appropriate maximal medical therapy for heart failure.\n7. Patient or legally authorized representative able to sign informed consent.\n\nExclusion Criteria:\n\n1. Evidence of Ischemic Heart Disease as determined by study cardiologist.\n2. Significant Valvular Disease. (AS with AVA \\\u003C1.5 and severe AR and MR)\n3. History of Familial Cardiomyopathy.\n4. Recent documented myocarditis within 2 months of enrollment.\n5. History of Infiltrative cardiomyopathy or restrictive cardiomyopathy.\n6. Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram.\n7. Liver function tests \\> 3 x upper limit of normal.\n8. NYHA class IV heart failure.\n9. Inotropic dependence.\n10. Unstable or life-threatening arrhythmia.\n11. For patients not on anticoagulants, INR\\>1.5\n12. Mechanical or Bioprosthetic heart valve.\n13. Cardiogenic shock.\n14. Breastfeeding and\u002For pregnant women.\n15. Autoimmune disorders on current immunosuppressive therapy.\n16. Active infection not responding to appropriate therapy as determined by Study Chair.\n17. Trastuzumab treatment within the last 3 months.\n18. Automatic implantable cardioverter defibrillator (AICD) placement within the last 30 days.\n19. AICD firing within the last 30 days.","ALL","18 Years","80 Years",{"count":90,"type":91},72,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","This randomized pilot phase I trial studies the side effects of donor bone marrow derived mesenchymal stem cells in controlling heart failure in patients with cardiomyopathy caused by anthracyclines. Donor bone marrow derived mesenchymal stem cells may help to control symptoms of heart failure and improve heart function.",[97,98,99,100],"Cardiomyopathy","Heart Failure","Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","2026-01-06",{"date":103,"type":104},"2026-01-07","ACTUAL",{"date":106,"type":104},"2020-07-18",{"date":108,"type":91},"2026-07-30",{"name":5,"class":6},1]