Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.
详细描述
Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure and are well supported by recent meta analyses of early clinical data sets. Concentrated autologous bone marrow mononuclear cells (ABM MNC) are the subject of the current study as they are supported by more clinical data than any other cell type described, and contain all of the potentially therapeutic cell factors from studies of selected cells. Study results demonstrate ABM MNC to be safe, and, when delivered intramyocardially as intended in the current study, results consistently support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization. The Treatment Group undergoes left ventricular catheterization and is treated with ABM MNC using the CardiAMP cell therapy system. The Control Group has a Control procedure consisting of left ventricular diagnostic catheterization but no introduction of the Helix transendocardial delivery catheter and no administration of ABM MNC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind including study participants and care provider (investigator) conducting outcomes assessments
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New York Heart Association (NYHA) Class II or III
- •Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol.
- •Left ventricular ejection fraction >20% and <40%
- •On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization.
- •NTproBNP level of >500 pg/ml
- •Autologous cell analysis score consistent with study selection assessment
排除标准
- •Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.
研究组 & 干预措施
Study (ABM MNC) Treatment
Left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system
干预措施: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system (Device)
Control Treatment
Left ventricular (diagnostic) catheterization but no administration of ABM MNC
干预措施: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system (Device)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
The primary efficacy endpoint is the comparison of a composite score based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events (heart failure hospitalization or a worsening heart failure, stroke or MI) ordered by time to event, excluding those deemed procedure related occurring within the first 7 days, and (3) change for quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLwHFQ)
次要结局
- First Secondary Endpoint(Baseline through study completion, maximum of two years)
- Second Secondary Endpoint(Baseline through study completion, maximum of two years)
- Third Secondary Endpoint(Baseline through study completion, maximum of two years)
- Fourth Secondary Endpoint(Baseline to 12 months, 24 months)
- Fifth Secondary Endpoint(Baseline to 12 months, 24 months)
- Sixth Secondary Endpoint(Baseline to 12 months, 24 months)
- Seventh Secondary Endpoint(Baseline through study completion, maximum of two years)