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Validating intramyocardial bone marrow stem cell therapy in combination with coronary artery bypass grafting, the PERFECT Phase III randomized multicenter trial: study protocol for a randomized…

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Title
Validating intramyocardial bone marrow stem cell therapy in combination with coronary artery bypass grafting, the PERFECT Phase III randomized multicenter trial: study protocol for a randomized controlled trial
Published in
Trials, July 2012
DOI 10.1186/1745-6215-13-99
Pubmed ID
Authors

Peter Donndorf, Alexander Kaminski, Gudrun Tiedemann, Guenther Kundt, Gustav Steinhoff

Abstract

For the last decade continuous efforts have been made to translate regenerative cell therapy protocols in the cardiovascular field from 'bench to bedside'. Successful clinical introduction, supporting safety, and feasibility of this new therapeutic approach, led to the initiation of the German, Phase III, multicenter trial - termed the PERFECT trial (ClinicalTrials.gov Identifier: NCT00950274), in order to evaluate the efficacy of surgical cardiac cell therapy on left ventricular function. The PERFECT trial has been designed as a prospective, randomized, double-blind, placebo controlled, multicenter trial, analyzing the effect of intramyocardial CD 133(+) bone marrow stem cell injection in combination with coronary artery bypass grafting on postoperative left ventricular function. The trial includes patients aged between 18 and 79 years presenting with a coronary disease with indication for surgical revascularization and reduced global left ventricular ejection fraction as assessed by cardiac magnet resonance imaging. The included patients are treated in the chronic phase of ischemic cardiomyopathy after previous myocardial infarction. Patients undergoing coronary artery bypass grafting in combination with intramyocardial CD133+ cell injection will have a higher LV ejection fraction than patient who undergo CABG alone, measured 6 months after the operation. ClinicalTrials.gov Identifier: NCT00950274.

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The data shown below were compiled from readership statistics for 64 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 64 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 9 14%
Researcher 9 14%
Student > Bachelor 8 13%
Student > Master 8 13%
Student > Postgraduate 4 6%
Other 9 14%
Unknown 17 27%
Readers by discipline Count As %
Medicine and Dentistry 27 42%
Agricultural and Biological Sciences 6 9%
Biochemistry, Genetics and Molecular Biology 4 6%
Nursing and Health Professions 2 3%
Psychology 1 2%
Other 4 6%
Unknown 20 31%