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CompletedNCT00316381Updated May 22, 2008

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

An interventional study of Autologous bone marrow-derived stem cells in Myocardial Infarction, sponsored by Silesian School of Medicine. Completed at 4 sites in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-05-22.

Sponsored by Silesian School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myocardial Infarction

Keywords

  • stem cells
  • acute myocardial infarction
  • regeneration
  • left ventricular ejection fraction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 200 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Silesian School of Medicine is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Acute myocardial infarction treated successfully with primary coronary angioplasty
  • Left ventricular ejection fraction less than 40%
  • Informed consent granted

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Interventions

  • ProcedureAutologous bone marrow-derived stem cells
06

What researchers measure

Primary outcomes

  1. Left ventricular ejection fraction and volumes measured by echocardiography

    Time frame: 6 months

  2. Left ventricular ejection fraction and volumes measured by angiography

    Time frame: 6 months

Secondary outcomes

  1. Safety

    Time frame: 6, 12 months

  2. Left ventricular function in dobutamine stress test

    Time frame: 6 months

  3. Coronary flow reserve by adenosine MRI test

    Time frame: 6 months

07

Study locations

4 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 15533859 ↗
  • 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. PubMed 16267071 ↗
  • 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. PubMed 15656779 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00316381
Lead sponsor
Silesian School of Medicine
Collaborators
Ministry of Science and Higher Education, Poland
First posted
Apr 20, 2006
Start date
Nov 2004
Primary completion
Mar 2008
Completion
Mar 2008
Last update
May 22, 2008

Study contacts

Michal Tendera, MD, PhD
principal investigator · Third Division of Cardiology Silesian School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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