Phase 1-2 Study of Intracoronary Infusion of CD133+ Endothelial Precursor Cells for Patients With Coronary Heart Disease in Selected Obstructed Artery
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Increased regional and global myocardial contractility measured by low-dose dobutamine echocardiography/MRI and increased myocardial perfusion measured by adenosine nuclear stress testing.
研究概览
简要总结
The aim of this study is to evaluate if the intracoronary infusion of autologous bone-marrow derived CD133+ endothelial precursor cells is able to promote neovascularization and to improve myocardial perfusion and contractility in patients with refractory coronary heart disease, characterized by poor response to standard coronary interventions, severe impairment of the quality of life, and poor prognosis.
详细描述
Refractory Coronary Artery Disease is a significant cause of mortality and decreased quality of life. Intracoronary infusion of CD133+ progenitor cells is a viable treatment option for patients with this condition. After clinical and laboratory evaluation, 50-100 ml of bone marrow will be obtained by bone marrow aspiration from the posterior iliac crest under local anesthesia. From this sample, CD133+ endothelial progenitor cells will be isolated, purified and packed within the next 12 hours of extraction, and resuspended in 30 ml saline solution. The patient will undergo coronary catheterization for selection of the target obstructed artery for cell infusion, which will be performed using a balloon catheter under hemodynamic monitoring. Once concluded, the patient will be transferred to intermediate care unit for post-interventional observation for approximately 24 hours before being released. Ambulatory follow-up will be performed at specific intervals to determine efficacy and safety of this intervention by clinical and laboratory examination, including imaging and cardiac function studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with proven CHD by coronary angiography demonstrating occlusion or extreme stenosis (> 90%) of a coronary artery (target artery) not suitable for angioplasty or surgery.
- •Angiographic criteria: Feasibility for balloon catheter placement without risks of obstruction of the left main coronary trunk.
- •Evidence of viable myocardial tissue in the area irrigated by the target artery by MRI (low dose dobutamine and late enhancement).
- •CCS class 2-4 angina pectoris (angina pectoris at rest and at light exertion, obvious reduction in the exertion capacity).
- •Optimal antianginal pharmacologic therapy (consistent with the current guidelines of ACC (American College of Cardiology), as well as the DGK (Deutsche Gesellschaft für Kardiologie)
- •Signed written consent form accepted by the Ethics Committee.
- •Effective contraception in women of child-bearing age.
排除标准
- •Severe symptomatic heart failure (NYHA class 4).
- •Myocardial aneurysm (in the target region) without evidence of viable myocardium.
- •Myocardial infarction in the last 4 weeks.
- •Symptomatic ventricular tachycardia.
- •Known malignancy.
- •Known hematological disease.
- •Renal insufficiency with creatinine > 2.5 mg/dl.
- •Pregnancy.
- •Active chronic inflammatory bowel disease or rheumatic disease with high parameters of inflammation (WBCs above 10/nl and increased C-reactive protein). Systemic steroid administration.
- •Severe coagulopathy or phenprocoumon type anticoagulation therapy at the time of bone marrow extraction.
- •Antiproliferative therapy (chemotherapy, etc.).
- •Non accordance with procedures and follow-up studies.
- •Contraindications to MRI studies.
- •Known hypersensitivity against mouse immunoglobulins.
- •Known hypersensitivity against ferridextran.
- •Contraindications for bone marrow extraction.
- •Cerebrovascular accident in the past four months.
结局指标
主要结局
Increased regional and global myocardial contractility measured by low-dose dobutamine echocardiography/MRI and increased myocardial perfusion measured by adenosine nuclear stress testing.
时间窗: Base-line, 3, and 6 months.
次要结局
- Reduction in the consumption of medicines for the heart ailment (nitrates, diuretics, etc.).(Base-line, 3, and 6 months.)
- Improvement in the heart failure functional class measured by NYHA and CCS classification tests.(Base-line, 3, and 6 months)
- Changes in the score of the "Minnessota living with heart failure score".(Base-line, 3, and 6 months.)
- Functional heart changes measured by spiroergometry.(Base-line, 3, and 6 months.)
- Safety and compatibility through evaluation of adverse events (death, supraventricular and ventricular arrhythmias, brain/peripheral ischemic events, myocardial infarct, malignancies, etc.).(Base-line, 3, and 6 months.)