A Randomized,Prospective,Double-blind Study to Evaluate Intracardiac Injections of Bone Marrow,Autologous CD133+Cells(Electromechanical Mapping Based)in Patients With Resistant Angina and no Effective Revascularization Option. RegentVsel
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Myocardial perfusion change
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of therapy with autological CD133+ cells in patients with angina resistant to pharmacological treatment and without the possibility of effective revascularization. Cells will be isolated from patients bone marrow and administered directly into the muscle of left ventricle. The main objective is to assess the treatments' influence on improvement of myocardial perfusion and function, and on decrease of occurrence of symptomatic angina.
详细描述
Patients with a Stable angina pectoris (CCS II-IV) can potentially benefit from treatment with autological CD133+ cell populations, which include cells with a higher expression of cardiac and endothelial differentiation markers.
REGENT VSEL Trial will include Patients with Angina resistant to pharmacological treatment and without the possibility of effective revascularization.
The main objective of the study is to assess the treatments influence on:
- improvement of myocardial perfusion
- global and segmental contractility (LVEF)
- occurrence of symptomatic angina
- quality of life
Regent Vsel is a prospective, randomized, double blind, placebo-controlled study with a planned number of 60 Patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina CCS II-IV despite maximum pharmacotherapy for at least 2 weeks since last medications change
- •Presence of ≥ 1 myocardial segment with ischemia features in Tc-99m SPECT
- •Patients disqualified from revascularization procedures by Heart Team
- •Patient age > 18 and < 75 year old
- •Patient must provide written informed consent for participation in study
排除标准
- •Acute coronary syndrome in less than 6 months prior to enrollment
- •Heart failure NYHA III-IV
- •Presence of intracardiac thrombus (echocardiography confirmed), massive calcification of the aortic valve and left ventricular aneurysm
- •Previous cardioverter-defibrillator or cardiac stimulator implantation
- •Allergy to contrast agents
- •History of malignancy
- •HIV, HBV, HCV infection
- •Life expectancy less than 6 months
- •Bleeding diathesis
- •Renal insufficiency (GFR < 30 mL/min/1.73m2)
- •Pregnancy, lactation, or ineffective contraception in women of childbearing potential
结局指标
主要结局
Myocardial perfusion change
时间窗: 4 months after application of cell therapy
Myocardial perfusion change assessed by perfusion scintigraphy (99mTc SPECT)
次要结局
- Occurrence of ventricular arrhythmia(1, 4, 6 and 12 months after application of cell therapy)
- Exercise tolerance(4 and 12 months after application of cell therapy)
- Global and segmental contractility change and myocardial perfusion change(MRI 4 months and echocardiography 4 and 12 months after application of cell therapy)
- Occurrence of symptomatic angina(1, 4, 6 and 12 months after application of cell therapy)
- Quality of life(1, 4, 6 and 12 months after application of cell therapy)
- Occurrence of in-stent restenosis and progression of artherosclerotic lesions in remained coronary artery segments(4 months after application of cell therapy)
研究者
Wojciech Wojakowski MD, PhD
MD, PhD
Medical University of Silesia