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

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ClinicalTrials.gov Identifier: NCT00316381
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : May 22, 2008
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Autologous bone marrow-derived stem cells Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myocardial REGeneration by Intracoronary Infusion of Selected Population of stEm Cells in Acute Myocardial iNfarcTion. Randomized Multicenter Trial
Study Start Date : November 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources




Primary Outcome Measures :
  1. Left ventricular ejection fraction and volumes measured by echocardiography [ Time Frame: 6 months ]
  2. Left ventricular ejection fraction and volumes measured by angiography [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 6, 12 months ]
  2. Left ventricular function in dobutamine stress test [ Time Frame: 6 months ]
  3. Coronary flow reserve by adenosine MRI test [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316381


Locations
Poland
III Division of Cardiology Silesian School of Medicine
Katowice, Poland, 40-653
Jagiellonian University Institute of Cardiology
Krakow, Poland, 31-202
Poznan University of Medical Sciences II Clinic of Cardiology
Poznan, Poland, 61-701
National Institute of Cardiology
Warszawa, Poland, 04-628
Sponsors and Collaborators
Silesian School of Medicine
Ministry of Science and Higher Education, Poland
Investigators
Principal Investigator: Michal Tendera, MD, PhD Third Division of Cardiology Silesian School of Medicine