临床试验/NCT00939042

NCT00939042终止不适用

Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells

Asklepios proresearch1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2009年1月1日最近更新: 2022年10月6日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方
入组人数: 40
试验地点: 1
主要终点: Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.

研究设计

研究类型: Interventional
分配方式: Non 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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
•conventional therapy according to the ESC guidelines for heart failure
•BMI > 20 and < 35

排除标准

•PCI elder then 21 days
•relevant valvular disease
•history of stroke/multivessel disease/thromboembolic event etc.
•DM Type I

结局指标

主要结局

Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).

时间窗: 12 months

次要结局

Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.(12 months)
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.(12 months)

研究者

发起方

Asklepios proresearch

申办方类型

Industry

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

终止

1 期

METHOD - Bone Marrow Derived Mononuclear Cells in Chronic Ischemic DiseaseChronic Ischemic Heart Disease

NCT01666132Cardiocentro Ticino10

进行中（未招募）

不适用

Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction using Bone Marrow Mononuclear Cells</full-title-trial - Alster Stem CellAcute myocardial infarction (LVEF<45%)ICD10: I21.9

EUCTR2008-004625-42-DEAsklepios Kliniken Hamburg GmbH25

已完成

2 期

Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD RecipientsVentricular DysfunctionHeart FailureCardiomyopathy

NCT02362646Annetine Gelijns159

暂停

2 期

Intramyocardial Delivery of Autologous Bone MarrowRefractory Angina

NCT00820586IRCCS San Raffaele13

终止

3 期

Intramyocardial Transplantation of Bone Marrow Stem Cells in Addition to Coronary Artery Bypass Graft (CABG) SurgeryCoronary Artery DiseaseMyocardial Ischemia

NCT00950274Miltenyi Biotec B.V. & Co. KG81