The Efficacy and Safety Assessment of Human Umbilical Cord Stroma-derived Multipotent Stromal Cells in Myocardial Infarction; a Phase 1/2 Clinical Trial (HUC-HEART Study)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- ventricular remodeling
研究概览
简要总结
The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery prior to the cell administration. This 2-year study comprise three independent groups, where the first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20), and third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells will be administered to the approximately 10 peri-infarct areas at one time. The infarct zone will be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80 years of age. The efficiency of the therapy will be evaluated according to the parameters measured by MR, SPECT, and Echocardiography. All subject were taken into those measurements prior and 6, 12, 18 and 24 months after the operation.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ischemic hearth disease who will experience CABG
- •%25<EF<%45
- •NYHA class II-IV patients
- •hemodynamically stable
排除标准
- •Patient's in approval
- •Acute cardiac decompensation
- •Acute myocardial infarction
- •Congenital heart disease
- •Additional surgical heart disease other than coronary artery disease
- •Malign arrhythmia
- •All malignancies
- •HbA1c level >%10 (86 mmol/mol) type II diabetes mellitus
- •Severe liver dysfunction
- •Severe COPD
- •Coagulopathy
- •Immunosuppressive treatment
- •Acute hepatitis, hepatitis B, C and HIV infection
- •Chronic liver and renal failure
- •Collagen tissue disease
- •Hematological diseases
- •Socially and mentally disabilities
结局指标
主要结局
ventricular remodeling
时间窗: within one year after cell transplantation
Outcome measures will be determined by cardiac MR, SPECT and PET monitoring to assess the left ventricular ejection fraction (%), left ventricle end-diastolic and end-systolic volumes (mL/m2), left ventricle mass (g/m2), infarct size (%), and the thickness of the dysfunctional wall (mm).
次要结局
未报告次要终点