Stem Cell Therapy to Improve Myocardial Function in Patients With Acute Myocardial Infarction

Not Applicable

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT00316381
• Lead Sponsor: Silesian School of Medicine

Brief Summary

The purpose of the study is to compare the efficiency of a sorted subpopulation of CD34+/CXCR4+ 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 CD34+/CXCR4+ 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 CD34+/CXCR4+ cells most likely contains the tissue-specific stem cells likely to be involved in myocardial salvage/regeneration 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 CD34/CXCR4+ 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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-20
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-20
• Last Update Posted: 2008-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Acute myocardial infarction treated successfully with primary coronary angioplasty
• Left ventricular ejection fraction less than 40%
• Informed consent granted

Exclusion Criteria

• Presence of significant coronary stenoses in non-infarct related artery requiring revascularization
• Cardiogenic shock
• Previous myocardial infarction
• Age < 18 years and > 75 years
• Pregnancy
• Neoplasm
• Contraindications for MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction and volumes measured by echocardiography	6 months
Left ventricular ejection fraction and volumes measured by angiography	6 months

Secondary Outcome Measures

Name	Time	Method
Safety	6, 12 months
Left ventricular function in dobutamine stress test	6 months
Coronary flow reserve by adenosine MRI test	6 months

Trial Locations

Locations (4)

Jagiellonian University Institute of Cardiology; 🇵🇱 Krakow, Poland

Poznan University of Medical Sciences II Clinic of Cardiology; 🇵🇱 Poznan, Poland

National Institute of Cardiology; 🇵🇱 Warszawa, Poland

III Division of Cardiology Silesian School of Medicine; 🇵🇱 Katowice, Poland