Heart Failure Clinical Trial
Bone Marrow Derived Mesenchymal Stem Cells in Improving Heart Function in Patients With Heart Failure Caused by Anthracyclines
Summary
This randomized pilot phase I trial studies the side effects and best method of delivery of bone marrow derived mesenchymal stem cells (MSCs) in improving heart function in patients with heart failure caused by anthracyclines (a type of chemotherapy drug used in cancer treatment). MSCs are a type of stem cell that can be removed from bone marrow and grown into many different cell types that can be used to treat cancer and other diseases, such as heart failure. Bone marrow derived MSCs may promote heart muscle cells repair and lead to reverse remodeling and ultimately improve heart function and decrease morbidity and mortality from progression to advanced heart failure.
Full Description
PRIMARY OBJECTIVE:
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.
Eligibility Criteria
Inclusion Criteria:
Patients with LVEF =< 40% from treatment with anthracyclines for all malignancies at any dose at any time without evidence of other causes of cardiomyopathy
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:
Evidence of ischemic heart disease as determined by study cardiologist
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
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There is 1 Location for this study
Houston Texas, 77030, United States
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