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

Information source: Silesian School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Infarction

Intervention: Autologous bone marrow-derived stem cells (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Silesian School of Medicine

Official(s) and/or principal investigator(s):
Michal Tendera, MD, PhD, Principal Investigator, Affiliation: Third Division of Cardiology Silesian School of Medicine

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.

Clinical Details

Official title: Myocardial REGeneration by Intracoronary Infusion of Selected Population of stEm Cells in Acute Myocardial iNfarcTion. Randomized Multicenter Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Left ventricular ejection fraction and volumes measured by echocardiography

Left ventricular ejection fraction and volumes measured by angiography

Secondary outcome:

Safety

Left ventricular function in dobutamine stress test

Coronary flow reserve by adenosine MRI test

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

III Division of Cardiology Silesian School of Medicine, Katowice 40-653, Poland

Jagiellonian University Institute of Cardiology, Krakow 31-202, Poland

Poznan University of Medical Sciences II Clinic of Cardiology, Poznan 61-701, Poland

National Institute of Cardiology, Warszawa 04-628, Poland

Additional Information

Related publications:

Wojakowski W, Tendera M, Michałowska A, Majka M, Kucia M, Maślankiewicz K, Wyderka R, Ochała 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. Epub 2004 Nov 8.

Wojakowski W, Tendera M, Zebzda A, Michalowska A, Majka M, Kucia M, Maslankiewicz K, Wyderka R, Król 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. Epub 2005 Nov 2.

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. Review.

Starting date: November 2004
Last updated: May 20, 2008

Page last updated: August 20, 2015

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