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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316381
• Other study ID #: REGENT
• Secondary ID: Grant PBZ-KBN-09
• Status: Completed
• Phase: N/A
• First received: April 18, 2006
• Last updated: May 20, 2008
• Start date: November 2004
• Est. completion date: March 2008

Study information

• Verified date: May 2008
• Source: Silesian School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Autologous bone marrow-derived stem cells

Locations

Country	Name	City	State
Poland	III Division of Cardiology Silesian School of Medicine	Katowice
Poland	Jagiellonian University Institute of Cardiology	Krakow
Poland	Poznan University of Medical Sciences II Clinic of Cardiology	Poznan
Poland	National Institute of Cardiology	Warszawa

Sponsors (2)

Lead Sponsor	Collaborator
Silesian School of Medicine	Ministry of Science and Higher Education, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. Epub 2004 Nov 8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction and volumes measured by echocardiography		6 months	No
Primary	Left ventricular ejection fraction and volumes measured by angiography		6 months	No
Secondary	Safety		6, 12 months	Yes
Secondary	Left ventricular function in dobutamine stress test		6 months	No
Secondary	Coronary flow reserve by adenosine MRI test		6 months	No