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
  Purpose

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 Intervention
Myocardial Infarction
Procedure: Autologous bone marrow-derived stem cells

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Silesian School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: November 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00316381     History of Changes
Other Study ID Numbers: REGENT, Grant PBZ-KBN-099/P05/2003
Study First Received: April 18, 2006
Last Updated: May 20, 2008
Health Authority: Poland: Ministry of Health

Keywords provided by Silesian School of Medicine:
stem cells
acute myocardial infarction
regeneration
left ventricular ejection fraction

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on October 19, 2014