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

NCT ID: NCT00316381

Last Updated: 2008-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction

Keywords

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stem cells acute myocardial infarction regeneration left ventricular ejection fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Autologous bone marrow-derived stem cells

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Higher Education, Poland

OTHER_GOV

Sponsor Role collaborator

Silesian School of Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Michal Tendera, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Third Division of Cardiology Silesian School of Medicine

Locations

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III Division of Cardiology Silesian School of Medicine

Katowice, , Poland

Site Status

Jagiellonian University Institute of Cardiology

Krakow, , Poland

Site Status

Poznan University of Medical Sciences II Clinic of Cardiology

Poznan, , Poland

Site Status

National Institute of Cardiology

Warsaw, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 15533859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16267071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15656779 (View on PubMed)

Dabrowski W, Tekieli L, Mazurek A, Lanocha M, Banys RP, Zmudka K, Majka M, Wojakowski W, Tendera M, Musialek P. Transcoronary stem cell transfer and evolution of infarct-related artery atherosclerosis: evaluation with conventional and novel imaging techniques including Quantitative Virtual Histology (qVH). Postepy Kardiol Interwencyjnej. 2022 Dec;18(4):483-495. doi: 10.5114/aic.2023.125609. Epub 2023 Feb 6.

Reference Type DERIVED
PMID: 36967840 (View on PubMed)

Other Identifiers

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Grant PBZ-KBN-099/P05/2003

Identifier Type: -

Identifier Source: secondary_id

REGENT

Identifier Type: -

Identifier Source: org_study_id