REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
NCT ID: NCT00279175
Last Updated: 2012-09-20
Study Results
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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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2004-04-30
2010-12-31
Brief Summary
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The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.
Detailed Description
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* Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included.
* All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
* After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed.
* After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMC
Intracoronary infusion of autologous bone marrow derived cells
Intracoronary infusion of enriched bone marrow-derived progenitor cells
Placebo
Intracoronary infusion of Placebo medium
Placebo medium supplemented with autologous serum
Interventions
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Intracoronary infusion of enriched bone marrow-derived progenitor cells
Placebo medium supplemented with autologous serum
Eligibility Criteria
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Inclusion Criteria
* Either acute PCI with stent implantation within 24 hours after symptom onset or
* treatment with thrombolysis within 12 hours of symptom onset followed by PCI with stent implantation within 24 hours after thrombolysis.
* Acute PCI / stent implantation has been successful (residual stenosis visually \< 30% and TIMI flow \>= 2).
* At the time of inclusion patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
* Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction \<= 45% on visual estimation).
* Maximal CK elevation \>= 400 U/l (measured at 37° C) with significant MB fraction \> 6%
* Age 18 - 80 Years
* Written informed consent
Exclusion Criteria
* Need to revascularize additional vessels, outside the infarct artery.
* Arteriovenous malformations or aneurysms
* Active infection (CRP \> 10 mg/dl) now, or fever or diarrhea within last 4 weeks.
* Chronic inflammatory disease
* HIV infection or active hepatitis
* Neoplastic disease without documented remission within the past 5 years.
* Cerebrovascular insult within 3 months
* Impaired renal function (creatinine \> 2 mg/dl) at the time of cell therapy
* Significant liver disease (GOT \> 2x upper limit) or spontaneous INR \> 1,5)
* Anemia (hemoglobin \< 8.5 mg/dl)
* Platelet count \< 100.000/µl
* Hypersplenism
* Known allergy or intolerance to clopidogrel, heparin or abciximab.
* History of bleeding disorder
* Gastrointestinal bleeding within 3 months
* Major surgical procedure or traumata within 2 months
* Uncontrolled hypertension
* Pregnancy
* Mental retardation
* Previously performed stem / progenitor cell therapy
* Participation in another clinical trial within the last 30 days.
18 Years
80 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Blutspendedienst Baden-Württemberg - Hessen
UNKNOWN
Guidant Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
A. M. Zeiher
OTHER
Responsible Party
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A. M. Zeiher
Professor Dr. med.
Principal Investigators
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Andreas M Zeiher, MD
Role: PRINCIPAL_INVESTIGATOR
J. W. Goethe University Hospitals
Volker Schächinger, MD
Role: STUDY_DIRECTOR
J. W. Goethe University Hopspitals
Locations
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Zentralklinik Bad Berka
Bad Berka, , Germany
Kerckhoff Klinik
Bad Nauheim, , Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
BG Kliniken Bergmannsheil
Bochum, , Germany
Klinikum Lippe
Detmold, , Germany
Rotes-Kreuz Krankenhaus - Kardiologisches Centrum
Frankfurt, , Germany
J. W. Goethe University Hospitals
Frankfurt, , Germany
Universitätsklinkum Giessen
Giessen, , Germany
Parxis Schofer, Mathey und Partner
Hamburg, , Germany
Universitätsklikum Homburg
Homburg/Saar, , Germany
Klinikum Kassel
Kassel, , Germany
Herzzentrum - Universität Leipzig
Leipzig, , Germany
Herzzentrum Ludwigshafen
Ludwigshafen, , Germany
Universitätsklinik Mainz
Mainz, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Zentralklinikum Suhl
Suhl, , Germany
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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References
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Schachinger V, Tonn T, Dimmeler S, Zeiher AM. Bone-marrow-derived progenitor cell therapy in need of proof of concept: design of the REPAIR-AMI trial. Nat Clin Pract Cardiovasc Med. 2006 Mar;3 Suppl 1:S23-8. doi: 10.1038/ncpcardio0441.
Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1210-21. doi: 10.1056/NEJMoa060186.
Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Werner N, Haase J, Neuzner J, Germing A, Mark B, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Improved clinical outcome after intracoronary administration of bone-marrow-derived progenitor cells in acute myocardial infarction: final 1-year results of the REPAIR-AMI trial. Eur Heart J. 2006 Dec;27(23):2775-83. doi: 10.1093/eurheartj/ehl388. Epub 2006 Nov 10.
Dill T, Schachinger V, Rolf A, Mollmann S, Thiele H, Tillmanns H, Assmus B, Dimmeler S, Zeiher AM, Hamm C. Intracoronary administration of bone marrow-derived progenitor cells improves left ventricular function in patients at risk for adverse remodeling after acute ST-segment elevation myocardial infarction: results of the Reinfusion of Enriched Progenitor cells And Infarct Remodeling in Acute Myocardial Infarction study (REPAIR-AMI) cardiac magnetic resonance imaging substudy. Am Heart J. 2009 Mar;157(3):541-7. doi: 10.1016/j.ahj.2008.11.011. Epub 2009 Jan 31.
Erbs S, Linke A, Schachinger V, Assmus B, Thiele H, Diederich KW, Hoffmann C, Dimmeler S, Tonn T, Hambrecht R, Zeiher AM, Schuler G. Restoration of microvascular function in the infarct-related artery by intracoronary transplantation of bone marrow progenitor cells in patients with acute myocardial infarction: the Doppler Substudy of the Reinfusion of Enriched Progenitor Cells and Infarct Remodeling in Acute Myocardial Infarction (REPAIR-AMI) trial. Circulation. 2007 Jul 24;116(4):366-74. doi: 10.1161/CIRCULATIONAHA.106.671545. Epub 2007 Jul 9.
Assmus B, Rolf A, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Tillmanns H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Tonn T, Dimmeler S, Dill T, Zeiher AM, Schachinger V; REPAIR-AMI Investigators. Clinical outcome 2 years after intracoronary administration of bone marrow-derived progenitor cells in acute myocardial infarction. Circ Heart Fail. 2010 Jan;3(1):89-96. doi: 10.1161/CIRCHEARTFAILURE.108.843243. Epub 2009 Dec 8.
Rolf A, Assmus B, Schachinger V, Rixe J, Mollmann S, Mollmann H, Dimmeler S, Zeiher AM, Hamm CW, Dill T. Maladaptive hypertrophy after acute myocardial infarction positive effect of bone marrow-derived stem cell therapy on regional remodeling measured by cardiac MRI. Clin Res Cardiol. 2011 Nov;100(11):983-92. doi: 10.1007/s00392-011-0330-3. Epub 2011 Jun 17.
Assmus B, Tonn T, Seeger FH, Yoon CH, Leistner D, Klotsche J, Schachinger V, Seifried E, Zeiher AM, Dimmeler S. Red blood cell contamination of the final cell product impairs the efficacy of autologous bone marrow mononuclear cell therapy. J Am Coll Cardiol. 2010 Mar 30;55(13):1385-94. doi: 10.1016/j.jacc.2009.10.059.
Other Identifiers
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Paul-Ehrlich-Institute 1034/01
Identifier Type: -
Identifier Source: secondary_id
EudraCT 2006-000250-43
Identifier Type: -
Identifier Source: secondary_id
2/04
Identifier Type: -
Identifier Source: org_study_id