Isolated Coronary Artery Bypass Graft Combined With Bone Marrow Mononuclear Cells Delivered Through a Graft Vessel for Patients With Previous Myocardial Infarction and Chronic Heart Failure

Abstract

In summary, patients with a previous MI and chronic heart failure could potentially benefit from isolated CABG (i.e., those who received CABG only) combined with BMMNCs delivered through a graft vessel. (Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting [CABG]; NCT00395811).

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

“…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).…”

“…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.…”

“…25 The remaining 15 trials compared treatment to no treatment. 10,19,20,23,24,26,30,37,[48][49][50][51][52][53][54] Twelve trails delivered the cells via the coronary arteries (IC), 10,22,26,[28][29][30]35,[48][49][50]52,54 whereas the remaining 19 trials injected the cells into the heart muscle (IM). …”

“…included a description of the method of randomization and allocation concealment, which included computerized methods, sealed envelopes, a telephone interactive voice-response system, colored ball selection, random number tables, and site-independent randomization, and the risk of selection bias in these trials was low. In 14 trials, 10,19,26,[28][29][30]34,35,37,48,50,52,54 no method of allocation concealment was reported, and therefore, these trials were considered to have an unclear risk of selection bias because of poor allocation concealment.…”

“…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. In one trial, 54 the list of predefined outcomes differed between 2 published reports, and this trial was therefore considered to have a high risk of reporting bias.…”