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      Intracoronary Injection of CD34 +-Cells in Chronic Ischemic Heart Failure: 7 Years Follow-Up of the DanCell Study

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          Abstract

          Objectives: Seven years ago, the DanCell study was carried out to test the hypothesis of improvement in left ventricular ejection fraction (LVEF) following repeated intracoronary injections of autologous bone marrow-derived stem cells (BMSCs) in patients suffering from chronic ischemic heart failure. In this post hoc analysis, the long-term effect of therapy is assessed. Methods: 32 patients [mean age 61 (SD ± 9), 81% males] with systolic dysfunction (LVEF 33 ± 9%) received two repeated intracoronary infusions (4 months apart) of autologous BMSCs (1,533 ± 765 × 10<sup>6</sup> BMSCs including 23 ± 11 × 10<sup>6</sup> CD34<sup>+</sup> cells and 14 ± 7 × 10<sup>6</sup> CD133<sup>+</sup> cells). Patients were followed for 7 years and deaths were recorded. Results: During follow-up, 10 patients died (31%). In univariate regression analysis, the total number of BMSCs, CD34<sup>+</sup> cell count and CD133<sup>+</sup> cell count did not significantly correlate with survival (hazard ratio: 0.999, 95% CI: 0.998-1.000, p = 0.24; hazard ratio: 0.94, 95% CI: 0.88-1.01, p = 0.10, and hazard ratio: 0.96, 95% CI: 0.87-1.07, p = 0.47, respectively). After adjustment for baseline variables in multivariate regression analysis, the CD34<sup>+</sup> cell count was significantly associated with survival (hazard ratio: 0.90, 95% CI: 0.82-1.00, p = 0.04). Conclusions: Intracoronary injections of a high number of CD34<sup>+</sup> cells may have a beneficial effect on chronic ischemic heart failure in terms of long-term survival.

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          Most cited references 5

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          ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC.

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            Administration of cardiac stem cells in patients with ischemic cardiomyopathy: the SCIPIO trial: surgical aspects and interim analysis of myocardial function and viability by magnetic resonance.

            SCIPIO is a first-in-human, phase 1, randomized, open-label trial of autologous c-kit(+) cardiac stem cells (CSCs) in patients with heart failure of ischemic etiology undergoing coronary artery bypass grafting (CABG). In the present study, we report the surgical aspects and interim cardiac magnetic resonance (CMR) results. A total of 33 patients (20 CSC-treated and 13 control subjects) met final eligibility criteria and were enrolled in SCIPIO. CSCs were isolated from the right atrial appendage harvested and processed during surgery. Harvesting did not affect cardiopulmonary bypass, cross-clamp, or surgical times. In CSC-treated patients, CMR showed a marked increase in both LVEF (from 27.5 ± 1.6% to 35.1 ± 2.4% [P=0.004, n=8] and 41.2 ± 4.5% [P=0.013, n=5] at 4 and 12 months after CSC infusion, respectively) and regional EF in the CSC-infused territory. Infarct size (late gadolinium enhancement) decreased after CSC infusion (by manual delineation: -6.9 ± 1.5 g [-22.7%] at 4 months [P=0.002, n=9] and -9.8 ± 3.5 g [-30.2%] at 12 months [P=0.039, n=6]). LV nonviable mass decreased even more (-11.9 ± 2.5 g [-49.7%] at 4 months [P=0.001] and -14.7 ± 3.9 g [-58.6%] at 12 months [P=0.013]), whereas LV viable mass increased (+11.6 ± 5.1 g at 4 months after CSC infusion [P=0.055] and +31.5 ± 11.0 g at 12 months [P=0.035]). Isolation of CSCs from cardiac tissue obtained in the operating room is feasible and does not alter practices during CABG surgery. CMR shows that CSC infusion produces a striking improvement in both global and regional LV function, a reduction in infarct size, and an increase in viable tissue that persist at least 1 year and are consistent with cardiac regeneration. This study is registered with clinicaltrials.gov, trial number NCT00474461.
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              Pilot study to evaluate the safety and feasibility of intracoronary CD133(+) and CD133(-) CD34(+) cell therapy in patients with nonviable anterior myocardial infarction.

              The long-term effect of intracoronary infusion of progenitor cells in patients with chronic ischemic cardiomyopathy. Bone marrow stem-cell administration in patients with myocardial infarction improved myocardial performance and in some studies contributed to favorable left ventricular remodeling. We report on the results of a pilot, single center, controlled safety, and feasibility study, including 24 patients with old, nonviable anterior myocardial infarction. Twelve patients underwent intracoronary administration of selected CD133(+) and CD133(-)CD34(+) progenitor cells and 12 were followed up on medical therapy. Left ventricular volumes and ejection fraction, at rest and during low-dose dobutamine, and myocardial viability, using TL-201 reinjection scintigraphy, were analyzed at baseline and long-term follow-up. Patients in the treatment group experienced a sustained decrease in left ventricular end-diastolic and end-systolic resting volumes (P = 0.008 and P = 0.002, respectively), as well as an improvement in global ejection fraction at rest [from (27.2 +/- 6.8)% to (29.7 +/- 7.3)%, P = 0.016]. Segmental anterior and apical wall perfusion, during TL-201 reinjection, were similarly improved (P = 0.005 and P < 0.001, respectively). One patient developed restenosis at the cell delivery site and one progression of atherosclerosis. During 28.0 +/- 8.7 months of clinical follow-up, only one patient experienced deterioration of heart failure. In the control group, we observed stability in the perfusion defect and deterioration in end-diastolic and end-systolic volumes (P= 0.002 and P = 0.003, respectively) and a nonsignificant decrease in ejection fraction (P = 0.11). Intracoronary infusion of selected CD133(+) and CD133(-)CD34(+) progenitor cells to a previously infarcted and nonviable anterior wall is safe, and results in sustained improvement in segmental myocardial perfusion and in favorable left ventricular remodeling. (c) 2007 Wiley-Liss, Inc.
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                Author and article information

                Journal
                CRD
                Cardiology
                10.1159/issn.0008-6312
                Cardiology
                S. Karger AG
                0008-6312
                1421-9751
                2014
                September 2014
                12 August 2014
                : 129
                : 2
                : 69-74
                Affiliations
                Departments of aCardiology, bEndocrinology and Metabolism, and cClinical Immunology, Odense University Hospital, Odense, Denmark
                Author notes
                *Axel Cosmus Pyndt Diederichsen, Department of Cardiology, Odense University Hospital, DK-5000 Odense C (Denmark), E-Mail axel.diederichsen@rsyd.dk
                Article
                363133 Cardiology 2014;129:69-74
                10.1159/000363133
                25116577
                © 2014 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 1, Tables: 3, Pages: 6
                Categories
                Original Research

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