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

This study has been completed.

Sponsor:

Collaborator:

Ministry of Science and Higher Education, Poland

Information provided by:

Silesian School of Medicine

ClinicalTrials.gov Identifier:

NCT00316381

First received: April 18, 2006

Last updated: May 20, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2006

Last Updated Date

May 20, 2008

Start Date ^ICMJE

November 2004

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Left ventricular ejection fraction and volumes measured by echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Left ventricular ejection fraction and volumes measured by angiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Left ventricular ejection fraction and volumes measured by echocardiography
Left ventricular ejection fraction and volumes measured by angiography
Left ventricular ejection fraction and volumes measured by cardiac MRI

Change History

Complete list of historical versions of study NCT00316381 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety [ Time Frame: 6, 12 months ] [ Designated as safety issue: Yes ]
Left ventricular function in dobutamine stress test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Coronary flow reserve by adenosine MRI test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety
Left ventricular function in dobutamine stress-test
Coronary flow reserve by adenosine MRI test

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Myocardial REGeneration by Intracoronary Infusion of Selected Population of stEm Cells in Acute Myocardial iNfarcTion. Randomized Multicenter Trial

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Infarction

Intervention ^ICMJE

Procedure: Autologous bone marrow-derived stem cells

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT00316381

Other Study ID Numbers ^ICMJE

REGENT, Grant PBZ-KBN-099/P05/2003

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Silesian School of Medicine

Collaborators ^ICMJE

Ministry of Science and Higher Education, Poland

Investigators ^ICMJE

Principal Investigator:

Michal Tendera, MD, PhD

Third Division of Cardiology Silesian School of Medicine

Information Provided By

Silesian School of Medicine

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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