A pilot trial of autologous bone marrow mononuclear cell transplantation through grafting artery: A sub-study focused on segmental left ventricular function recovery and scar reduction

Lu, Minjie; Liu, Sheng; Zheng, Zhe; Yin, Gang; Song, Lingyun; Chen, Huaibing; Chen, Xiuyu; Chen, Qi-Yin; Jiang, Shiliang; Tian, Lu; He, Zhaoyi; Hu, Shengshou; Zhao, Shihua

doi:10.1016/j.ijcard.2013.01.217

Cited by 31 publications

(23 citation statements)

References 32 publications

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“…However, in 8 trials 19,26,32,36,43,50,52,55 that reported LVEF values at time of follow-up, meta-analysis showed significant difference in mean change from baseline values in favor of cell treatment (MD 4.02%, 95% CI 1.09% to 6.96%, P=0.007; Figure 5B). These results were also confirmed in ischemic HF trials only (MD 3.57%, 95% CI 0.30% to 6.84%, P=0.03).…”

Section: Left Ventricular Ejection Fractionmentioning

confidence: 96%

“…In 4 trials that reported mean change in LVEF from baseline values, 9,19,32,36 meta-analysis showed no significant difference in mean change from baseline values between groups (MD 1.26%, 95% CI −3.08% to 5.59%, P=0.57). However, in 8 trials 19,26,32,36,43,50,52,55 that reported LVEF values at time of follow-up, meta-analysis showed significant difference in mean change from baseline values in favor of cell treatment (MD 4.02%, 95% CI 1.09% to 6.96%, P=0.007; Figure 5B).…”

Section: Left Ventricular Ejection Fractionmentioning

confidence: 96%

“…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%

“…Twelve trials 9,19,21,26,32,36,39,43,50,52,55 reported LVEF after long-term follow-up, although 1 trial 21 only reported summary results with no data. One trial 39 only reported control values graphically with no clear detail of measure of variation and was therefore excluded from the analysis.…”

Section: Left Ventricular Ejection Fractionmentioning

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

188

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: Left Ventricular Ejection Fractionmentioning

confidence: 96%

Section: Left Ventricular Ejection Fractionmentioning

confidence: 96%

Section: Data Extractionmentioning

confidence: 99%

Section: Left Ventricular Ejection Fractionmentioning

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

188

158

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“…Even in clinical trials, structural and functional parameters, carried out by several imaging techniques, remain as conventional endpoints. A significant part of the clinical trials do not resort to any kind of molecular monitoring [81][82][83][84]88,89,92,94] and when they do, they are limited to some conventional cardiac markers (Table 1), mainly BNP [90,96], NT-proBNP [77][78][79][80]86,87,91,93], in addition to creatine kinase [77,86,87,90,[95][96][97], troponins I [90,96,97] and T [77,80,86,87] and some inflammation markers, such as TNF-α, IL-6 [79] and C-reactive protein [77,86]. Therefore, we suggest to screen biofluids (Box 5, Fig.…”

Section: Clinical Translationmentioning

confidence: 99%

Towards the standardization of stem cell therapy studies for ischemic heart diseases: Bridging the gap between animal models and the clinical setting

Trindade

Leite‐Moreira

Ferreira-Martins

et al. 2017

International Journal of Cardiology

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Today there is an increasing demand for heart transplantations for patients diagnosed with heart failure. Though, shortage of donors as well as the large number of ineligible patients hurdle such treatment option. This, in addition to the considerable number of transplant rejections, has driven the clinical research towards the field of regenerative medicine. Nonetheless, to date, several stem cell therapies tested in animal models fall by the wayside and when they meet the criteria to clinical trials, subjects often exhibit modest improvements. A main issue slowing down the admission of such therapies in the domain of human trials is the lack of protocol standardization between research groups, which hampers comparison between different approaches as well as the lack of thought regarding the clinical translation. In this sense, given the large amount of reports on stem cell therapy studies in animal models reported in the last 3 years, we sought to evaluate their advantages and limitations towards the clinical setting and provide some suggestions for the forthcoming investigations. We expect, with this review, to start a new paradigm on regenerative medicine, by evoking the debate on how to plan novel stem cell therapy studies with animal models in order to achieve more consistent scientific production and accelerate the admission of stem cell therapies in the clinical setting.

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