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

Last updated: May 20, 2008
Sponsor: Silesian School of Medicine
Overall Status: Completed

Phase

N/A

Condition

Myocardial Ischemia

Congestive Heart Failure

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00316381
REGENT
Grant PBZ-KBN-099/P05/2003
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Acute myocardial infarction treated successfully with primary coronary angioplasty

  • Left ventricular ejection fraction less than 40%

  • Informed consent granted

Exclusion

Exclusion Criteria:

  • Presence of significant coronary stenoses in non-infarct related artery requiringrevascularization

  • Cardiogenic shock

  • Previous myocardial infarction

  • Age < 18 years and > 75 years

  • Pregnancy

  • Neoplasm

  • Contraindications for MRI

Study Design

Total Participants: 200
Study Start date:
November 01, 2004
Estimated Completion Date:
March 31, 2008

Study 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.

Connect with a study center

  • III Division of Cardiology Silesian School of Medicine

    Katowice, 40-653
    Poland

    Site Not Available

  • Jagiellonian University Institute of Cardiology

    Krakow, 31-202
    Poland

    Site Not Available

  • Poznan University of Medical Sciences II Clinic of Cardiology

    Poznan, 61-701
    Poland

    Site Not Available

  • National Institute of Cardiology

    Warszawa, 04-628
    Poland

    Site Not Available

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