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| ID | Type | Description | Link |
|---|---|---|---|
| Grant PBZ-KBN-099/P05/2003 |
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| Name | Class |
|---|---|
| Ministry of Science and Higher Education, Poland | OTHER_GOV |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow-derived stem cells | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction and volumes measured by echocardiography | 6 months | |
| Left ventricular ejection fraction and volumes measured by angiography | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 6, 12 months | |
| Left ventricular function in dobutamine stress test | 6 months | |
| Coronary flow reserve by adenosine MRI test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Tendera, MD, PhD | Third Division of Cardiology Silesian School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| III Division of Cardiology Silesian School of Medicine | Katowice | 40-653 | Poland | |||
| Jagiellonian University Institute of Cardiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15533859 | Background | 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. | |
| 16267071 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 6 months |
| Krakow |
| 31-202 |
| Poland |
| Poznan University of Medical Sciences II Clinic of Cardiology | Poznan | 61-701 | Poland |
| National Institute of Cardiology | Warsaw | 04-628 | Poland |
| Background |
| 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. |
| 15656779 | Background | 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. |
| 36967840 | Derived | 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |