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

May 20, 2008 updated by: Silesian School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Katowice, Poland, 40-653
        • III Division of Cardiology Silesian School of Medicine
      • Krakow, Poland, 31-202
        • Jagiellonian University Institute of Cardiology
      • Poznan, Poland, 61-701
        • Poznan University of Medical Sciences II Clinic of Cardiology
      • Warszawa, Poland, 04-628
        • National Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular ejection fraction and volumes measured by echocardiography
Time Frame: 6 months
6 months
Left ventricular ejection fraction and volumes measured by angiography
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 6, 12 months
6, 12 months
Left ventricular function in dobutamine stress test
Time Frame: 6 months
6 months
Coronary flow reserve by adenosine MRI test
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silesian School of Medicine

Collaborators

Ministry of Science and Higher Education, Poland

Investigators

  • Principal Investigator: Michal Tendera, MD, PhD, Third Division of Cardiology Silesian School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 20, 2006

Study Record Updates

Last Update Posted (Estimate)

May 22, 2008

Last Update Submitted That Met QC Criteria

May 20, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Autologous bone marrow-derived stem cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe