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Myocardial InfarctionNCT00316381

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

A study testing Autologous bone marrow-derived stem cells in people with Myocardial Infarction, run by Silesian School of Medicine at 4 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Autologous bone marrow-derived stem cells
Type of treatment
Surgery or procedure
How many people
200 participants
Where
4 sitesPoland
Study dates
Nov 2004to Mar 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Poland4 sites

  • III Division of Cardiology Silesian School of Medicine

    Katowice, 40-653

  • Jagiellonian University Institute of Cardiology

    Krakow, 31-202

  • Poznan University of Medical Sciences II Clinic of Cardiology

    Poznan, 61-701

  • National Institute of Cardiology

    Warsaw, 04-628

Other trials in Poland

About this study

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

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.

Being tested
Autologous bone marrow-derived stem cells
Keywords
stem cells, acute myocardial infarction, regeneration, left ventricular ejection fraction
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous bone marrow-derived stem cellsProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular ejection fraction and volumes measured by echocardiography

    Measured: 6 months

  2. Left ventricular ejection fraction and volumes measured by angiography

    Measured: 6 months

Secondary outcomes (3)

  1. Safety

    Measured: 6, 12 months

  2. Left ventricular function in dobutamine stress test

    Measured: 6 months

  3. Coronary flow reserve by adenosine MRI test

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2006 (estimated)
  2. Study startNov 2004
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00316381
Sponsor's protocol ID
REGENT
Other IDs
Grant PBZ-KBN-099/P05/2003
Status last verified
May 2008
First submitted
18 Apr 2006
Last updated
22 May 2008
Results posted
No
Data monitoring committee
Yes

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

  • 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.

    PubMed 36967840

Questions about this trial

What is this clinical trial studying?

A study testing Autologous bone marrow-derived stem cells in people with Myocardial Infarction, run by Silesian School of Medicine at 4 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular ejection fraction and volumes measured by echocardiography (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00316381, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.

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