Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
NCT ID: NCT00669227
Last Updated: 2014-06-10
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
PHASE2
42 participants
INTERVENTIONAL
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration
autologous stem cells
intracoronary administration at the same day of cell aspiration using the stop flow technique
2
placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration
placebo suspension
intracoronary administration at the same day as cell aspiration
Interventions
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autologous stem cells
intracoronary administration at the same day of cell aspiration using the stop flow technique
placebo suspension
intracoronary administration at the same day as cell aspiration
Eligibility Criteria
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Inclusion Criteria
* clear target vessel
* large myocardial infarction defined as: proximal vessel occlusion, CK \> 1000 U/L, myocardial scar in magnetic resonance imaging \> 10% of left ventricular muscle mass
* potential prior thrombolysis
* written informed consent
Exclusion Criteria
* prior myocardial infarction
* no clear target vessel
* contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
* severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
* prior hematologic disease
* prior chemo therapy
* prior stem cell transplantation
* prior treatment with G-CSF
* known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
* local infection of puncture sites
35 Years
75 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Jochen Wohrle
Prof. Dr. Jochen Wöhrle
Principal Investigators
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Jochen Wöhrle, MD; FESC
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Locations
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University of Ulm
Ulm, , Germany
Countries
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References
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Wohrle J, Merkle N, Mailander V, Nusser T, Schauwecker P, von Scheidt F, Schwarz K, Bommer M, Wiesneth M, Schrezenmeier H, Hombach V. Results of intracoronary stem cell therapy after acute myocardial infarction. Am J Cardiol. 2010 Mar 15;105(6):804-12. doi: 10.1016/j.amjcard.2009.10.060.
Wohrle J, von Scheidt F, Schauwecker P, Wiesneth M, Markovic S, Schrezenmeier H, Hombach V, Rottbauer W, Bernhardt P. Impact of cell number and microvascular obstruction in patients with bone-marrow derived cell therapy: final results from the randomized, double-blind, placebo controlled intracoronary Stem Cell therapy in patients with Acute Myocardial Infarction (SCAMI) trial. Clin Res Cardiol. 2013 Oct;102(10):765-70. doi: 10.1007/s00392-013-0595-9. Epub 2013 Jul 30.
Other Identifiers
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SCAMI 01-04
Identifier Type: -
Identifier Source: org_study_id
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