Intravenous Administration of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) in Patients With Recent Onset Anthracycline-Associated Cardiomyopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Incidence of adverse events of intravenous injection of human mesenchymal stem cells (hMSCs) in patients with recent onset left ventricular systolic dysfunction from anthracyclines
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Laboratory Biomarker Analysis (Other)
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.
干预措施: Standard of Care (Other)
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.
干预措施: Mesenchymal Stem Cell Transplantation (Drug)
Arm II (standard of care drugs)
Patients receive only standard of care drugs for heart failure.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (standard of care drugs)
Patients receive only standard of care drugs for heart failure.
干预措施: Standard of Care (Other)
Arm II (standard of care drugs)
Patients receive only standard of care drugs for heart failure.
干预措施: Mesenchymal Stem Cell Transplantation (Drug)
结局指标
主要结局
Incidence of adverse events of intravenous injection of human mesenchymal stem cells (hMSCs) in patients with recent onset left ventricular systolic dysfunction from anthracyclines
时间窗: Up to 6 months
Statistical analyses of safety will be descriptive. In particular, will provide a table of adverse events.
次要结局
- Change in improvement in left ventricular systolic function by 7 points(Baseline up to 6 months)
- Development of acute heart failure decompensation(Up to 6 months)
- Emergency center visits for heart failure(Up to 6 months)
- Need for new pacemaker/automatic implantable cardioverter defibrillator(Up to 6 months)
- New onset arrhythmias(Up to 6 months)
- Sudden cardiac death(Up to 6 months)
- Acute pulmonary edema(Up to 6 months)
- Asymptomatic decrease in left ventricular ejection fraction (LVEF) of > 10%(Baseline to up to 6 months)
- Heart failure admission(Up to 6 months)
- Progression free survival(Up to 12 months)