Randomized Study of Mononuclear Bone Marrow Cell Transplantation in Patients With Coronary Surgery

Zhao, Qiang; Sun, Yongxin; Xia, Limin; Chen, Anqing; Wang, Zhe

doi:10.1016/j.athoracsur.2008.08.068

Cited by 103 publications

(83 citation statements)

References 32 publications

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“…The study of Zhao corroborated with the previous investigations, and verified the benefit of intramyocardial injections of MNC during CABG in patients with severe impaired EF postinfarction on global and regional myocardial function and perfusion (Zhao et al, 2008). Very interesting non-randomized, case control study comes from Thailand's group, who used thoracoscopic delivery of in-vitro expanded endothelial progenitors (EPC) isolated from the peripheral blood into the peri-infarction area (Arom et al, 2008).…”

Section: Transplantation Of Progenitor Cells and Recovery Of LV Functsupporting

confidence: 58%

Stem Cell Therapy in Myocardial Infarction Clinical Point of View and the Results of the REANIMA Study (REgenerAtion of Myocardium with boNe Marrow Mononuclear Cells in MyocArdial Infarction)

Obradović¹,

Balint²,

Trifunović³

2011

Stem Cells in Clinic and Research

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Section: Transplantation Of Progenitor Cells and Recovery Of LV Functsupporting

confidence: 58%

Stem Cell Therapy in Myocardial Infarction Clinical Point of View and the Results of the REANIMA Study (REgenerAtion of Myocardium with boNe Marrow Mononuclear Cells in MyocArdial Infarction)

Obradović¹,

Balint²,

Trifunović³

2011

Stem Cells in Clinic and Research

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“…Most of the studies have entailed direct intracoronary infusions of mononuclear cells in patients with acute myocardial infarction, 26 and it is clear that they have reported an excellent safety record, particularly with regard to arrhythmias, which may be due to the intrinsically low arrhythmogenicity of these cells, but also to the route of delivery and the clinical setting. The importance of the latter 2 factors is illustrated by the fact that intramyocardial injections of bone marrow cells, either in conjunction with coronary artery bypass 27 or isolated 28 in patients with ischemic or nonischemic chronic heart failure, respectively, have also raised arrhythmia-associated safety concerns. As for intravenous injections of MSC, their safety can be predicted from the intramyocardial dispersion of the few cells that home to the target myocardial areas, 29 thereby resulting in a MSC:cardiomyocyte ratio probably too low for being proarrhythmic.…”

Section: Clinical Datamentioning

confidence: 99%

Stem Cell Therapy for Heart Failure

Menasché

2009

Circulation

110

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Abstract-So far, the major safety issue raised by the use of stem cells for cardiac repair has been the occurrence of ventricular arrhythmias, particularly after skeletal myoblast transplantation. Although one cannot refute a potential intrinsic arrhythmogenicity of stem cells, primarily related to their common lack of electromechanical integration into the recipient myocardium, it is also important to recognize that patients eligible for cell replacement therapy are prone to develop arrhythmias because of their underlying ischemic heart disease. Another confounding factor is the method used for the intramyocardial delivery of the cells, which can cause enough inflammatory tissue damage to further increase ventricular irritability on top of an already high baseline level. Thus any strategy designed to minimize the risk of stem cell-associated ventricular arrhythmias should take into account, besides the cell-specific ability to appropriately couple with host cardiomyocytes, the method of cell transfer and the nature of the myocardial environment targeted for cell engraftment. A more accurate characterization of the baseline risk of arrhythmias in these patients would thus be helpful for better assessing the respective contribution of the donor cells and the host myocardium to these complications. The risk-to-benefit ratio of stem cell therapy will finally have to be revisited in light of the fact that because this baseline risk is usually high, most of these patients will in any way be fitted with an implantable defibrillator. Key Words: arrhythmia Ⅲ cells Ⅲ heart failure Ⅲ myocardial infarction Ⅲ stem cells T he clinical acceptance of any new therapy is largely based on the risk-to-benefit ratio. In the case of stem cell treatment for chronic heart failure, the clinical results have so far been marginally successful, when not negative, whereas the concern that intramyocardial delivery of cells, particularly skeletal myoblasts, could cause potentially life-threatening ventricular arrhythmias has been repeatedly raised. However, in this specific context of heart failure, the legitimate emphasis on this safety issue may have led to somewhat underscore the fact that most of the patients eligible for cell replacement therapy are at high risk of arrhythmias because of their underlying ischemic heart disease to such an extent that they are now increasingly fitted with internal cardioverterdefibrillators (ICDs). 1 The objective of the present article is thus to highlight the fact that the proarrhythmic risk of stem cell therapy may not be entirely related to the cells themselves and to show that at least 2 other factors (ie, the mode of their delivery and the nature of the target substrate) can also be important contributors to posttransplantation arrhythmias. These factors should definitely be taken into account by any strategy aimed at reducing the arrhythmic risk of stem cell therapy. Summary of Experimental Data on StemCell-Induced ArrhythmiasBasically, there are 3 major mechanisms that can cause arrhythmias: reent...

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“…37,42,51 Finally, 1 trial administered adipose-derived regenerative cells obtained by liposuction and followed by enzymatic digestion of the adipose tissue, cell separation, and cell elution using commercially available devices. 21 The cell dose ranged from 5×10 Fifteen trials compared cells with a placebo, 9,11,21,22,28,29,[31][32][33][34][35]42,44 generally consisting of a cell-free solution, either the participants own serum or a saline solution containing heparin. One trial used a mock injection procedure in the control arm instead of a cell-free solution.…”

Section: Characteristics Of the Included Trialsmentioning

confidence: 99%

“…The primary outcomes of this Where multiple times of follow-up were reported, data were extracted for the longest possible duration of shortterm and long-term follow-up. The authors of 18 trials were contacted for clarification of data, including apparent discrepancies and insufficient detail in the reporting of methods or results 19,[22][23][24][25][26][27][28][29] or for mean and standard deviation values of outcomes where not explicitly reported 11,19,25,[30][31][32][33][34][35][36] or where reported graphically. 9,10,[37][38][39] Responses were obtained from authors of 7 trials (see Acknowledgments section).…”

Section: Data Extractionmentioning

confidence: 99%

Meta-Analysis of Cell Therapy Trials for Patients With Heart Failure

Fisher

Dorée

Mathur

et al. 2015

Circulation Research

191

158

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Rationale: Cell-based therapies are a promising intervention for the treatment of heart failure (HF) secondary to ischemic and nonischemic cardiomyopathy. However, the clinical efficacy of such new treatment requires further evaluation. Objective: To assess available clinical evidence on the safety and efficacy of cell-based therapies for HF. Methods and Results: Electronic databases (CENTRAL, DARE, NHSEED & HTA, PubMed, MEDLINE, EMBASE, CINAHL, LILACS, KoreaMed, PakMediNet, IndMed, and the Transfusion Evidence Library) were searched for relevant randomized controlled trials to June 2014. Trials of participants with HF and where the administration of any dose of autologous cells by any delivery route was compared with no intervention or placebo were eligible for inclusion. Primary outcomes were defined as mortality and rehospitalization as a result of HF. Secondary outcomes included performance status, quality of life, incidence of arrhythmias, brain natriuretic peptide levels, left ventricular ejection fraction, myocardial perfusion, and adverse events. Thirty-one independent trials (1521 participants) were included. The treatment significantly reduced the risk of mortality and rehospitalization caused by HF. There was a significant improvement in favor of stem cell treatment in performance status and exercise capacity, left ventricular ejection fraction, and quality of life. The treatment was also associated with a reduction of brain natriuretic peptide levels and no increase in the incidence of arrhythmias. However, there was considerable risk of performance, selection, and reporting bias among the included trials. Conclusions: This study shows evidence that autologous cell therapy may be beneficial for patients having HF, but further evidence is required.

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Randomized Study of Mononuclear Bone Marrow Cell Transplantation in Patients With Coronary Surgery

Cited by 103 publications

References 32 publications

Stem Cell Therapy in Myocardial Infarction Clinical Point of View and the Results of the REANIMA Study (REgenerAtion of Myocardium with boNe Marrow Mononuclear Cells in MyocArdial Infarction)

Stem Cell Therapy in Myocardial Infarction Clinical Point of View and the Results of the REANIMA Study (REgenerAtion of Myocardium with boNe Marrow Mononuclear Cells in MyocArdial Infarction)

Stem Cell Therapy for Heart Failure

Meta-Analysis of Cell Therapy Trials for Patients With Heart Failure

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