Autologous bone marrow-derived stem cell therapy in heart disease: Discrepancies and contradictions

Francis, Dárrel P.; Mielewczik, Michael; Zargaran, David; Cole, Graham D.

doi:10.1016/j.ijcard.2013.04.152

Cited by 56 publications

(54 citation statements)

References 46 publications

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“…1-4 Those meta-analyses were based on information from published papers and included different patient populations, follow-up (FUP) times, and outcome measures, resulting in data heterogeneity, due to inconsistent clinical definitions and parameters. Additionally, publication-based meta-analyses may include studies that were later withdrawn or that contained publication errors, 5 and they may exclude important trials that reported median values of skewed data. In contrast, individual patient data (IPD)-based meta-analyses contain transparent, controlled data, with unique definitions; this approach allows analyses of specific subgroups and generation of prognostic models.…”

Section: Introductionmentioning

confidence: 99%

Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in Patients With Acute Myocardial Infarction Based on Individual Patient Data

Gyöngyösi¹,

Wojakowski²,

Lemarchand³

et al. 2015

Circ Res

267

227

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Rationale The ACCRUE (Meta-Analysis of Cell-based CaRdiac stUdiEs) is the first prospectively declared collaborative multinational database including individual data of patients (IPD) with ischemic heart disease treated with cell therapy. Objective We analyzed the safety and efficacy of intracoronary cell therapy after acute myocardial infarction (AMI) including IPDs from 12 randomized trials (ASTAMI, Aalst, BOOST, BONAMI, CADUCEUS, FINCELL, REGENT, REPAIR-AMI, SCAMI, SWISS-AMI, TIME, LATE-TIME; n=1252). Methods and Results The primary endpoint was freedom from combined major adverse cardiac and cerebrovascular events (MACCE; including all-cause death, re-AMI, stroke, and target vessel revascularization). The secondary endpoint was freedom from hard clinical endpoints (death, re-AMI, or stroke), assessed with random-effects meta-analyses and Cox regressions for interactions. Secondary efficacy endpoints included changes in end-diastolic volume (ΔEDV), end-systolic volume (ΔESV), and ejection fraction (ΔEF), analyzed with random-effects meta-analyses and analysis of covariance. We reported weighted mean differences between cell therapy and control groups. No effect of cell therapy on MACCE (14.0% vs. 16.3%, hazard ratio 0.86, 95%CI: 0.63;1.18) or death (1.4% vs 2.1%) or death/re-AMI/stroke (2.9% vs 4.7%) was identified in comparison to controls. No change in ΔEF (mean difference: 0.96%, 95%CI: −0.2;2.1), ΔEDV, or ΔESV was observed compared to controls. These results were not influenced by anterior AMI location, reduced baseline EF, or the use of MRI for assessing left ventricular parameters. Conclusions This meta-analysis of IPD from randomized trials in patients with recent AMI revealed that intracoronary cell therapy provided no benefit, in terms of clinical events or changes in left ventricular function.

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Section: Introductionmentioning

confidence: 99%

Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in Patients With Acute Myocardial Infarction Based on Individual Patient Data

Gyöngyösi¹,

Wojakowski²,

Lemarchand³

et al. 2015

Circ Res

267

227

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“…The host university commendably published reports [9,18,19] but did not clearly request retraction. Without a request from an author or an institution, journals can feel paralysed, even over papers making statements that are biologically non-credible and mathematically impossible [20]. For example, though we presented to the NEJM and the EHJ reasons that might be scientifically sufficient to set aside DECREASE I [21,22] the journals had no request from an author or institution and therefore felt limited to issuing expression of concern [23], or an editor note that an investigation had taken place [24].…”

Section: Daring To Question Is Always Acceptablementioning

confidence: 99%

Grateful receipt of clarifications on a perioperative trial: An illustration of the duty of readers to ask questions

Cole

Shun-Shin

Finegold

et al. 2015

International Journal of Cardiology

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“…More than 600 discrepancies were noted. In an earlier analysis of 48 reports from a single group, 200 discrepancies were identified including “conflicts in recruitment dates, criteria, sample sizes…cell counts…fractional numbers of patients… arithmetical miscalculations, statistical errors, suppression of significant changes, exaggerated descriptions of findings, possible silent patient deletions…identical results with contradictory sample sizes, contradictory results with identical sample sizes…” (63). Elsewhere in the stem cell arena, debate is in progress around similar analyses that raised important questions (64–67).…”

Section: Translating Stem Cell Research To the Treatment Of Cardiac Dmentioning

confidence: 99%

Translating Stem Cell Research to Cardiac Disease Therapies

Rosen

Myerburg

Francis

et al. 2014

Journal of the American College of Cardiology

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Over the past 2 decades, there have been numerous stem cell studies focused on cardiac diseases, ranging from proof-of-concept to phase 2 trials. This series of articles focuses on the legacy of these studies and the outlook for future treatment of cardiac diseases with stem cell therapies. The first section by Rosen and Myerburg is an independent review that analyzes the basic science and translational strategies supporting the rapid advance of stem cell technology to the clinic, the philosophies behind them, trial designs, and means for going forward that may impact favorably on progress. The second and third sections were collected in response to the initial section of this review. The commentary by Francis and Cole discusses the Rosen and Myerburg review and details how trial outcomes can be affected by noise, poor trial design (particularly the absence of blinding), and normal human tendencies toward optimism and denial. The final, independent article by Marbán takes a different perspective concerning the potential for positive impact of stem cell research applied to heart disease and future prospects for its clinical application.

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Autologous bone marrow-derived stem cell therapy in heart disease: Discrepancies and contradictions

Cited by 56 publications

References 46 publications

Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in Patients With Acute Myocardial Infarction Based on Individual Patient Data

Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in Patients With Acute Myocardial Infarction Based on Individual Patient Data

Grateful receipt of clarifications on a perioperative trial: An illustration of the duty of readers to ask questions

Translating Stem Cell Research to Cardiac Disease Therapies

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