Bone Marrow Derived Mesenchymal Stem Cells in Improving Heart Function in Patients With Heart Failure Caused by Anthracyclines
NCT ID: NCT02408432
Last Updated: 2022-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2016-01-11
2021-12-08
Brief Summary
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Detailed Description
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I. To demonstrate the safety of allogeneic human mesenchymal stem cells (hMSCs) administered by intravenous infusion in patients with left ventricular (LV) dysfunction and heart failure secondary to chemotherapy with anthracyclines.
SECONDARY OBJECTIVE:
I. To demonstrate the efficacy of allogeneic hMSCs administered by intravenous infusion in patients with left ventricular dysfunction (left ventricular ejection fraction \[LVEF\] \< 40%) and heart failure secondary to treatment with anthracyclines.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive allogeneic hMSCs intravenously (IV) over 10-20 minutes once weekly for 4 weeks and standard of care drugs for heart failure.
ARM II: Patients receive only standard of care drugs for heart failure.
After completion of study treatment, patients are followed up monthly for 6 months and then at 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (hMSCs)
Patients receive allogeneic hMSCs IV over 10-20 minutes once weekly for 4 weeks and standard of care drugs for heart failure.
Laboratory Biomarker Analysis
Correlative studies
Standard of Care
Undergo mesenchymal stem cell infusion
Mesenchymal Stem Cell Transplantation
Undergo mesenchymal stem cell infusion
Arm II (standard of care drugs)
Patients receive only standard of care drugs for heart failure.
Laboratory Biomarker Analysis
Correlative studies
Standard of Care
Undergo mesenchymal stem cell infusion
Mesenchymal Stem Cell Transplantation
Undergo mesenchymal stem cell infusion
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Standard of Care
Undergo mesenchymal stem cell infusion
Mesenchymal Stem Cell Transplantation
Undergo mesenchymal stem cell infusion
Eligibility Criteria
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Inclusion Criteria
* Documented New York Heart Association (NYHA) class I, II and III
* Been treated with appropriate maximal medical therapy for heart failure
* Able to perform 6 minute walk test
* Patient or legally authorized representative able to sign informed consent
* Patients with persistent LV dysfunction 90 days after discontinuation of trastuzumab
Exclusion Criteria
* Significant valvular disease; (aortic stenosis \[AS\] with aortic valve area \[AVA\] \< 1.5 and severe aortic regurgitation \[AR\] and mitral regurgitation \[MR\])
* History of familial cardiomyopathy
* Recent documented myocarditis within 2 months of consent
* History of infiltrative cardiomyopathy or restrictive cardiomyopathy
* Epidermal growth factor receptor (eGFR) \< 50 by Mayo or Cockcroft formula
* Liver function tests \> 3 x upper limit of normal
* NYHA class IV heart failure
* Inotropic dependence
* Unstable or life-threatening arrhythmia
* Coagulopathy international normalized ratio (INR) \> 1.5
* Mechanical or bioprosthetic heart valve
* Cardiogenic shock
* Breast feeding and/or pregnant women
* Autoimmune disorders on current immunosuppressive therapy
* Active infection not responding to appropriate therapy as determined by study chair
* Trastuzumab treatment within the last 3 months
18 Years
80 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Amanda Olson
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2015-00969
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-0519
Identifier Type: OTHER
Identifier Source: secondary_id
2014-0519
Identifier Type: -
Identifier Source: org_study_id
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