A double-blind, randomized, controlled, multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction

Povsic, Thomas J.; O’Connor, Christopher M.; Henry, Timothy D.; Taussig, Andrew; Kereiakes, Dean J.; Fortuin, F. David; Niederman, Alan; Schatz, Richard; Spencer, Richard G.; Owens, Douglas K; Banks, Missy; Joseph, Diane; Roberts, Rhonda; Alexander, John H.; Sherman, Warren

doi:10.1016/j.ahj.2011.07.020

Cited by 97 publications

(67 citation statements)

References 23 publications

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“…[42][43][44] For dichotomous variables, count data were summed across groups and for continuous variables, the mean and standard deviation of the combined group was calculated from the mean and standard deviations of each subgroup.…”

Section: Discussionmentioning

confidence: 99%

“…In a further 14 trials, 19,24,26,28,31,32,37,42,44,48,[50][51][52][53] all outcomes mentioned in the methods were reported in the results, although it would be difficult to rule out selective reporting, and these trials were therefore considered to have an unclear risk of reporting bias. The risk of bias was also unclear in 7 other trials in which either one predefined secondary outcome was not reported, 20,34 one reported outcome was not included in the trial registration or protocol, 10,35,49 or in the case of 2 trials, 29 interim results of secondary outcomes only were presented.…”

Section: Evaluation Of Risk Of Biasmentioning

confidence: 99%

“…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%

“…20 One trial administered cardiac stem cells, obtained from a right atrial appendage biopsy followed by magnetic separation and culture of c-kit-positive cells. 49 The remaining 4 trials isolated SM from muscle biopsies followed by culture of the cells ex vivo and identification of a SM population 37,42,44,51 containing ≥50% of CD56-positive cells. 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.…”

Section: Characteristics Of the Included Trialsmentioning

confidence: 99%

“…The inclusion criteria were met by 36 full text articles, [9][10][11][42][43][44][48][49][50][51][52][53][54][55][56] which described 31 independent trials with a total of 1521 randomized participants (cells, 882; no cells, 639). Two studies 9,29 randomized participants separately to 2 different cell intervention groups, each with a comparative placebo arm; in these studies, the 2 groups were considered as independent trials unless results were reported for a combined control group, in which case the 2 intervention groups were combined for consistency and to avoid double counting of controls.…”

Section: Characteristics Of the Included Trialsmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Evaluation Of Risk Of Biasmentioning

confidence: 99%

Section: Characteristics Of the Included Trialsmentioning

confidence: 99%

Section: Characteristics Of the Included Trialsmentioning

confidence: 99%

Section: Characteristics Of the Included Trialsmentioning

confidence: 99%

See 3 more Smart Citations

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

Fisher

Dorée

Mathur

et al. 2015

Circulation Research

191

158

View full text Add to dashboard Cite

show abstract

Concepts of Cell Therapy and Myocardial Regeneration

Vadakke‐Madathil¹,

Chaudhry²

2022

Interventional Cardiology

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Pathophysiology of Myocardial Infarction

Frangogiannis

2015

Comprehensive Physiology

523

391

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Myocardial infarction is defined as sudden ischemic death of myocardial tissue. In the clinical context, myocardial infarction is usually due to thrombotic occlusion of a coronary vessel caused by rupture of a vulnerable plaque. Ischemia induces profound metabolic and ionic perturbations in the affected myocardium and causes rapid depression of systolic function. Prolonged myocardial ischemia activates a "wavefront" of cardiomyocyte death that extends from the subendocardium to the subepicardium. Mitochondrial alterations are prominently involved in apoptosis and necrosis of cardiomyocytes in the infarcted heart. The adult mammalian heart has negligible regenerative capacity, thus the infarcted myocardium heals through formation of a scar. Infarct healing is dependent on an inflammatory cascade, triggered by alarmins released by dying cells. Clearance of dead cells and matrix debris by infiltrating phagocytes activates anti-inflammatory pathways leading to suppression of cytokine and chemokine signaling. Activation of the renin-angiotensin-aldosterone system and release of transforming growth factor-β induce conversion of fibroblasts into myofibroblasts, promoting deposition of extracellular matrix proteins. Infarct healing is intertwined with geometric remodeling of the chamber, characterized by dilation, hypertrophy of viable segments, and progressive dysfunction. This review manuscript describes the molecular signals and cellular effectors implicated in injury, repair, and remodeling of the infarcted heart, the mechanistic basis of the most common complications associated with myocardial infarction, and the pathophysiologic effects of established treatment strategies. Moreover, we discuss the implications of pathophysiological insights in design and implementation of new promising therapeutic approaches for patients with myocardial infarction.

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A double-blind, randomized, controlled, multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction

Cited by 97 publications

References 23 publications

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

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

Concepts of Cell Therapy and Myocardial Regeneration

Pathophysiology of Myocardial Infarction

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