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| ID | Type | Description | Link |
|---|---|---|---|
| KKF 10-02 | |||
| KKF 04-03 |
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| Name | Class |
|---|---|
| Wilhelm Sander Foundation | UNKNOWN |
| Schulz Foundation | UNKNOWN |
| Else Kröner Fresenius Foundation | OTHER |
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The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size.
Experimental studies and early-phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem cells that are available cells for myocardial regeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days. |
|
| 2 | Placebo Comparator | Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF Granulocyte-Colony Stimulating Factor | Drug | Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of infarct size (measured by Tc-sestamibi scintigraphy) | measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction | Left ventricular ejection fraction | |
| Incidence of angiographic restenosis | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Schomig, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum | Munich | 80636 | Germany | |||
| 671. Medizinische Klinik, Klinikum rechts der Isar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11504914 | Background | Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Mobilized bone marrow cells repair the infarcted heart, improving function and survival. Proc Natl Acad Sci U S A. 2001 Aug 28;98(18):10344-9. doi: 10.1073/pnas.181177898. Epub 2001 Aug 14. | |
| 11283669 | Background |
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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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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D000078224 | Lenograstim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Placebo | Other | Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days. |
|
| Munich |
| 81675 |
| Germany |
| Kocher AA, Schuster MD, Szabolcs MJ, Takuma S, Burkhoff D, Wang J, Homma S, Edwards NM, Itescu S. Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function. Nat Med. 2001 Apr;7(4):430-6. doi: 10.1038/86498. |
| 15723072 | Background | Harada M, Qin Y, Takano H, Minamino T, Zou Y, Toko H, Ohtsuka M, Matsuura K, Sano M, Nishi J, Iwanaga K, Akazawa H, Kunieda T, Zhu W, Hasegawa H, Kunisada K, Nagai T, Nakaya H, Yamauchi-Takihara K, Komuro I. G-CSF prevents cardiac remodeling after myocardial infarction by activating the Jak-Stat pathway in cardiomyocytes. Nat Med. 2005 Mar;11(3):305-11. doi: 10.1038/nm1199. Epub 2005 Feb 20. |
| 16507801 | Result | Zohlnhofer D, Ott I, Mehilli J, Schomig K, Michalk F, Ibrahim T, Meisetschlager G, von Wedel J, Bollwein H, Seyfarth M, Dirschinger J, Schmitt C, Schwaiger M, Kastrati A, Schomig A; REVIVAL-2 Investigators. Stem cell mobilization by granulocyte colony-stimulating factor in patients with acute myocardial infarction: a randomized controlled trial. JAMA. 2006 Mar 1;295(9):1003-10. doi: 10.1001/jama.295.9.1003. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |