Viewing Study NCT00316381



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Study NCT ID: NCT00316381
Status: COMPLETED
Last Update Posted: 2008-05-22
First Post: 2006-04-18

Brief Title: Stem Cell Therapy to Improve Myocardial Function in Patients With Acute Myocardial Infarction
Sponsor: Silesian School of Medicine
Organization: Silesian School of Medicine

Study Overview

Official Title: Myocardial REGeneration by Intracoronary Infusion of Selected Population of stEm Cells in Acute Myocardial iNfarcTion Randomized Multicenter Trial
Status: COMPLETED
Status Verified Date: 2008-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of the study is to compare the efficiency of a sorted subpopulation of CD34CXCR4 cells and unselected bone marrow-derived progenitor cells in the treatment of patients with acute myocardial infarction and a low left ventricular ejection fraction
Detailed Description: Aim is to compare the efficiency of sorted subpopulation of CD34CXCR4 cells and unselected bone-marrow-derived progenitor cells in treatment of patients with acute myocardial infarction and low left ventricular ejection fraction The subpopulation of CD34CXCR4 cells most likely contains the tissue-specific stem cells likely to be involved in myocardial salvageregeneration after ischemic injury This approach is novel and original because so far no study identified the type of cells that actually contribute to stem cell-induced improvement in myocardial function in patients with AMI which were treated with unselected population of cells The REGENT trial prospective randomized multicentre trial comparing unselected BM mononuclear cells and sorted CD34CXCR4 cells in patients with myocardial infarction and low left ventricular ejection fraction successfully treated with primary percutaneous coronary angioplasty within 12 hours after the onset of chest pain The cells are delivered by intracoronary infusion Efficiency is assessed by cardiac magnetic resonance imaging echocardiography and left ventricular angiography

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
Grant PBZ-KBN-099P052003 None None None