EUCTR2006-006404-11-DE进行中（未招募）不适用
INTRAMYOCARDIAL TRANSPLANTATION OF BONE MARROW STEM CELLS FOR IMPROVEMENT OF POST-INFARCT MYOCARDIAL REGENERATION IN ADDITION TO CABG SURGERY: a controlled prospective, randomized, double blinded multicenter trial - PERFECT
Miltenyi Biotec GmbH0 个研究点目标入组 142 人开始时间: 2007年8月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Coronary artery disease after myocardial infarction with indication for CABG surgery
- •2. Currently reduced global LVEF assessed at site by cardiac MRI at rest (25% = LVEF = 50%)
- •3. Presence of a localized akinetic/hypokinetic/hypoperfused area of LV myocardium for defining the target area
- •4. Informed consent of the patient
- •5.18 years = Age < 80 years
- •6. Are not pregnant and do not plan to become pregnant during the study. Females with childbearing potential must provide a negative pregnancy test within 1-7 days before OP and must be using oral or injectable contraception (non childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 142
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 142
排除标准
- •Patients will be entered into this study only if they meet none of the following criteria:
- •1. Emergency operation
- •2. Presence of any moderate-severe valvular heart disease requiring concomitant valve replacement or reconstruction
- •3. Medical History of recent resuscitation in combination with ventricular arrhythmia classified by LOWN = class II
- •4. Acute myocardial infarction within last 2 weeks
- •5. Debilitating other disease: Degenerative neurologic disorders, psychiatric disease, terminal renal failure requiring dialysis, previous organ transplantation, active malignant neoplasia, or any other serious medical condition that, in the opinion of the investigator is likely to alter the patient’s course of recovery or the evaluation of the study medication’s safety
- •6. Impaired ability to comprehend the study information
- •7. Absence of written informed consent
- •8. Treatment with any investigational drug within the previous 30 days
- •9. Apparent infection (c-reactive protein [CRP] = 20 mg/L, fever = 38.5°C)
- •10. Contraindication for MRI scan
- •11. Immune compromise including active infection with Hepatitis B, C, HIV virus or seropositivity for Treponema pallidum
- •12. Pregnant or breast feeding
- •13. Childbearing potential with unreliable birth control methods
- •14. Have previously been enrolled in this study, respectively phase I and phase II
- •15. Known hypersensitivity or sensitization against murine products and human-anti-mouse-antibody-titer = 1:1000.
- •16. Contraindication to bone marrow aspiration
- •17. Known hypersensitivity against iron dextrane
研究者
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