Clinical trial NCT00316381: 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
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: stem cells
acute myocardial infarction
regeneration
left ventricular ejection fraction
Lead sponsor: Silesian School of Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Higher Education, Poland
First posted: 2006-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Left ventricular ejection fraction and volumes measured by echocardiography
timeFrame: 6 months
measure: Left ventricular ejection fraction and volumes measured by angiography
timeFrame: 6 months
Secondary outcomes:
measure: Safety
timeFrame: 6, 12 months
measure: Left ventricular function in dobutamine stress test
timeFrame: 6 months
measure: Coronary flow reserve by adenosine MRI test
timeFrame: 6 months
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: III Division of Cardiology Silesian School of Medicine
city: Krakow
country: Poland
facility: Jagiellonian University Institute of Cardiology
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences II Clinic of Cardiology
city: Warszawa
country: Poland
facility: National Institute of Cardiology
Study officials:
affiliation: Third Division of Cardiology Silesian School of Medicine
name: Michal Tendera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.