Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP Cell Therapy System in Patients With Refractory Angina Pectoris and Chronic Myocardial Ischemia (CardiAMP CMI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 343
- 试验地点
- 2
- 主要终点
- Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol
研究概览
简要总结
Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment
Treatment Group:
Subjects treated with aBMC using the CardiAMP cell therapy system
Sham Control Group:
Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)
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
Quadruple-blinded, placebo-controlled study. Patients, investigators, the CRO, core labs and the sponsor will be blinded for individual treatment adjudication.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 21 to 80 years of age
- •Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
- •Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.
- •Evidence of inducible myocardial ischemia on baseline stress testing
- •Obstructive coronary disease unsuitable for conventional revascularization
- •Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).
- •Able to complete an exercise tolerance test on the treadmill
- •Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.
- •Qualification of a pre-procedure screening of bone-marrow aspiration
排除标准
- •Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
研究组 & 干预措施
CardiAMP cell therapy system
Roll-in phase:
Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase.
In the subsequent randomized phase:
Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system.
干预措施: CardiAMP Cell Therapy System (Device)
Sham procedure control
Randomized phase:
Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells)
干预措施: Sham Treatment (Other)
结局指标
主要结局
Change from Baseline in Total Exercise Time on the treadmill using the Modified Bruce Protocol
时间窗: Baseline and 6 months visit
A superiority analysis with regards to change from Baseline in Total Exercise Time at the 6 months follow-up visit (using a Modified Bruce Protocol).
次要结局
- Safety: Total Major adverse cardiac events (MACE) at 12 months follow-up(From randomisation to 12 month follow-up)
- Efficacy: Percentage of patients with at least 1 Serious Adverse Event (SAE)(From randomization to 12 Months follow-up)
- Safety: overall survival at 6 months follow-up(at 6 months follow-up)
- Efficacy: Change of angina frequency (per week) at 12 months follow-up(Baseline and at 12 months follow-up)
- Efficacy: Change from baseline in Total Exercise Time at 6 months follow-up(Baseline and at 6 months follow-up)
- Efficacy: Change of Angina Frequency (per week) at 6 months follow-up(Baseline and at 6 months follow-up)
- Safety: Total Major adverse cardiac events (MACE) at 6 months follow-up(from randomisation to 6 months follow-up)