Intracoronary Injection of CD133+ Autologous Hematopoietic Cells After Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
研究概览
简要总结
TITLE Intracoronary injection of CD133+ autologous hematopoietic cells after myocardial infarction.
TRIAL DESIGN Pilot phase I/II parallel group study, with an untreated control group.
SPONSOR IRCCS Ospedale Maggiore Policlinico Milano INDICATION Acute myocardial infarction (AMI). TARGET POPULATION Patients (pts) with AMI treated with Primary Coronary Angioplasty (PTCA) with successful recanalization but unsuccessful reperfusion (myocardial blush (MB) grade 0 or 1 and less than 70% ST segment elevation resolution (STeR) (see Poli et al., Circulation, 2002).
OBJECTIVES Primary:
- To evaluate the safety of intracoronary injection of CD133+ cells from autologous bone marrow (ABM) and mobilized peripheral blood (MPB) in the target population.
- To evaluate the efficacy, of the selective injection of CD133+ cells from ABM and MPB in the culprit vessel of the target population, on regional and global contractile function and on perfusion and metabolism of the infarcted area, depending on cell dose and comparing to controls.
Secondary: 3. To evaluate the disease-related morbility of the target population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent;
- •age: 18-65 years;
- •large acute myocardial infarction (due to proximal occlusion of the left anterior descending or the right coronary artery) after successful primary PTCA carried out between the IV and the XXIV hour from the onset of AMI symptoms;
- •signs of microvascular dysfunction in the infarcted area: absence of STeR and angiographic MB, graded according to the dye density score (see van't Hof et al., Circulation, 1998); life expectancy more than 6 months.
排除标准
- •Pregnancy;
- •indication to aorto-coronaric by-pass;
- •neoplasia (previous or in progress);
- •primary diseases of the BM;
- •diabetes;
- •immunosuppressive therapy;
- •laboratory alterations of protein S, protein C, ATIII or Fibrinogen;
- •severe co-morbidity.
结局指标
主要结局
myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),
Ejection fraction (%) evaluated by 2D echocardiography;
次要结局
- perfusion/metabolism mismatch (P/Mm) evaluated by PET with Fluorine-18 fluorodeoxyglucose (FDG);
- Left Ventricular Wall Motion Score Index (LVWMSI) evaluated by 2D