Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With a Myocardial Infarction and Ischemic Left Ventricular Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 135
- 试验地点
- 32
- 主要终点
- Number of Participants Experiencing Any of the Adjudicated Events
研究概览
简要总结
The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
CAP-1002 Allogeneic Cardiosphere-Derived Cells
干预措施: CAP-1002 Allogeneic Cardiosphere-Derived Cells (Biological)
结局指标
主要结局
Number of Participants Experiencing Any of the Adjudicated Events
时间窗: Within 1-month post-infusion
Adjudicated Events reported included: Acute myocarditis; Death due to ventricular tachycardia (VT) or ventricular fibrillation (VF); Sudden unexpected death (defined as occurring within one hour of symptom onset, or un- witnessed death); and Major adverse cardiac event (MACE) (defined as the composite incidence of death, non- fatal recurrent MI, hospitalization for heart failure, emergency room treatment for heart failure, left ventricular assist device \[LVAD\] placement or heart transplant).
Percent Change From Baseline in Myocardium Mass Infarct Size at Month 12
时间窗: Baseline, Month 12
Infarct size, expressed as a percentage, was calculated by dividing the sum of infarct areas from all sections by the sum of left ventricular (LV) areas from all sections (including those without infarct scar) and multiplying by 100. Percent improvement in infarct size defined by scar as a percent of LV mass was assessed by magnetic resonance imaging. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value \*100%.
次要结局
- Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12(Baseline, Month 6 and Month 12)
- Percent Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12(Baseline, Month 6 and Month 12)
- Change From Baseline in Six-Minute Walk Test at Month 6 and 12(Baseline, Month 6 and Month 12)
- Change From Baseline in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Score at Month 6 and 12(Baseline, Month 6 and Month 12)
- Number of Participants Experiencing Any of the Adjudicated Events(Up to Month 12 post-infusion)
- Percent Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 and 12(Baseline, Month 6 and Month 12)
- Absolute Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12(Baseline, Month 6 and Month 12)
- Percent Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) at Month 6 and 12(Baseline, Month 6 and Month 12)
- Absolute Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12(Baseline, Month 6 and Month 12)
- Percent Change From Baseline in Left Ventricular End Systolic Volume (LVESV) at Month 6 and 12(Baseline, Month 6 and Month 12)
- Absolute Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12(Baseline, Month 6 and Month 12)
- Percent Change From Baseline in Infarct Size (Scar Tissue Mass) at Month 6 and 12(Baseline, Month 6 and Month 12)
- Absolute Change From Baseline in Viable Mass at Month 6 and 12(Baseline, Month 6 and Month 12)
- Percent Change From Baseline in Viable Mass at Month 6 and12(Baseline, Month 6 and Month 12)
- Absolute Change From Baseline in Function of the Region Receiving CAP-1002 Therapy at Month 6 and 12(Baseline, Month 6 and Month 12)
- Change From Baseline in Short Form (36) (SF-36) Scale Score at Month 6 and 12(Baseline, Month 6 and Month 12)
- Percent Change From Baseline in Myocardium Mass Infarct Size at Month 6 and 12(Baseline, Month 6 and Month 12)
- Change From Baseline in Log Transformed N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12(Baseline, Month 6 and Month 12)
- Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) Score at Month 6 and 12(Baseline, Month 6 and Month 12)
- Number of Participants With Change From Baseline in Patient Global Assessment (PGA) Score at Month 6 and 12(Baseline, Month 6 and Month 12)
- Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Month 6 and 12(Baseline, Month 6 and Month 12)
- Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) Biomarker at Month 6 and 12(Baseline, Month 6 and Month 12)