Stem Cell Therapy to Improve Myocardial Function in Patients With Acute Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Autologous bone marrow-derived stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring stem cells, acute myocardial infarction, regeneration, left ventricular ejection fraction
Eligibility 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
Sites / Locations
- III Division of Cardiology Silesian School of Medicine
- Jagiellonian University Institute of Cardiology
- Poznan University of Medical Sciences II Clinic of Cardiology
- National Institute of Cardiology
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction and volumes measured by echocardiography
Left ventricular ejection fraction and volumes measured by angiography
Secondary Outcome Measures
Safety
Left ventricular function in dobutamine stress test
Coronary flow reserve by adenosine MRI test
Full Information
NCT ID
NCT00316381
First Posted
April 18, 2006
Last Updated
May 20, 2008
Sponsor
Silesian School of Medicine
Collaborators
Ministry of Science and Higher Education, Poland
1. Study Identification
Unique Protocol Identification Number
NCT00316381
Brief Title
Stem Cell Therapy to Improve Myocardial Function in Patients With Acute Myocardial Infarction
Official Title
Myocardial REGeneration by Intracoronary Infusion of Selected Population of stEm Cells in Acute Myocardial iNfarcTion. Randomized Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Silesian School of Medicine
Collaborators
Ministry of Science and Higher Education, Poland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
stem cells, acute myocardial infarction, regeneration, left ventricular ejection fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Autologous bone marrow-derived stem cells
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction and volumes measured by echocardiography
Time Frame
6 months
Title
Left ventricular ejection fraction and volumes measured by angiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety
Time Frame
6, 12 months
Title
Left ventricular function in dobutamine stress test
Time Frame
6 months
Title
Coronary flow reserve by adenosine MRI test
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Tendera, MD, PhD
Organizational Affiliation
Third Division of Cardiology Silesian School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
III Division of Cardiology Silesian School of Medicine
City
Katowice
ZIP/Postal Code
40-653
Country
Poland
Facility Name
Jagiellonian University Institute of Cardiology
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Poznan University of Medical Sciences II Clinic of Cardiology
City
Poznan
ZIP/Postal Code
61-701
Country
Poland
Facility Name
National Institute of Cardiology
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
15533859
Citation
Wojakowski W, Tendera M, Michalowska A, Majka M, Kucia M, Maslankiewicz K, Wyderka R, Ochala A, Ratajczak MZ. Mobilization of CD34/CXCR4+, CD34/CD117+, c-met+ stem cells, and mononuclear cells expressing early cardiac, muscle, and endothelial markers into peripheral blood in patients with acute myocardial infarction. Circulation. 2004 Nov 16;110(20):3213-20. doi: 10.1161/01.CIR.0000147609.39780.02. Epub 2004 Nov 8.
Results Reference
background
PubMed Identifier
16267071
Citation
Wojakowski W, Tendera M, Zebzda A, Michalowska A, Majka M, Kucia M, Maslankiewicz K, Wyderka R, Krol M, Ochala A, Kozakiewicz K, Ratajczak MZ. Mobilization of CD34(+), CD117(+), CXCR4(+), c-met(+) stem cells is correlated with left ventricular ejection fraction and plasma NT-proBNP levels in patients with acute myocardial infarction. Eur Heart J. 2006 Feb;27(3):283-9. doi: 10.1093/eurheartj/ehi628. Epub 2005 Nov 2.
Results Reference
background
PubMed Identifier
15656779
Citation
Kucia M, Ratajczak J, Ratajczak MZ. Bone marrow as a source of circulating CXCR4+ tissue-committed stem cells. Biol Cell. 2005 Feb;97(2):133-46. doi: 10.1042/BC20040069.
Results Reference
background
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Stem Cell Therapy to Improve Myocardial Function in Patients With Acute Myocardial Infarction
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