Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial

Janssens, Stefan; Dubois, Christophe; Bogaert, Jan; Theunissen, Koen; Deroose, Christophe M.; Desmet, Walter; Kalantzi, Maria; Herbots, Lieven; Sinnaeve, Peter; Dens, Joseph; Maertens, Johan; Rademakers, Frank; Dymarkowski, Steven; Gheysens, Olivier; Cleemput, Johan Van; Bormans, Guy; Nuyts, Johan; Belmans, Ann; Mortelmans, Luc; Boogaerts, Marc; Werf, Frans Van de

doi:10.1016/s0140-6736(05)67861-0

Cited by 1,176 publications

(710 citation statements)

References 39 publications

Supporting

Mentioning

668

Contrasting

Unclassified

Order By: Relevance

“…In contrast, there was no improvement in cardiac function in the study conducted by Janssens et al 8 From baseline to 4 months after infarction, the LVEF increased by 2.2% in the control patients and 3.4% in patients who received stem cells. Possible explanation would be that ventricular function in this group of patients was well preserved to expect functional improvement from stem cell infusion.…”

Section: Lvef Change Noted In Individual Studiesmentioning

confidence: 79%

“…The modalities used to evaluate change in global ejection fraction included magnetic resonance imaging (MRI), 6,8,9 LV angiography, 4,5 cardiac echocardiography, 6,7,10 and single photon emission computed tomography (SPECT). 6 We did not attempt to reclassify outcomes retrospectively, because such an attempt would not only be impractical, but would also create the potential for bias.…”

Section: Data Synthesis and Analysismentioning

confidence: 99%

“…Our search yielded 7 randomized controlled trials (Suárez de Lezo et al, 4 Schächinger et al, 5 Lunde et al, 6 Ge et al, 7 Janssens et al, 8 Wollert et al, 9 and Chen et al 10 ), evaluating changes in LVEF following intracoronary BMC therapy in relation to control groups. A meta-analysis of 516 patients (BMC group, 256; control group, 260) was performed (Table 1 and 2).…”

Section: Study Selectionmentioning

confidence: 99%

“…All were doubleblind, placebo controlled trials. Follow-up for the studies for which data was reported was 100% in all but 1 study (Janssens et al, 8 1 patient died in the BMC group). Results of the Heterogeneity Test: As the heterogeneity test yielded a low P value (P<.05), the fixed effect model was invalid.…”

Section: Study Selectionmentioning

confidence: 99%

“…The variation in the LVEF could also be due to the fact that different modalities were used for the estimation of LVEF in the various trials included for meta-analysis: MRI, 6,8,9 LV angiography, 4,5 cardiac echocardiography, 6,7,10 and SPECT. 6 …”

Section: Limitationsmentioning

confidence: 99%

See 4 more Smart Citations

Stem Cells Improve Left Ventricular Function in Acute Myocardial Infarction

Singh

Arora

Handa

et al. 2009

Clinical Cardiology

View full text Add to dashboard Cite

BackgroundAnimal studies have suggested dramatic improvement in cardiac function after acute myocardial infarction (AMI) through regeneration of the myocardium or neovascularization by transfer of cells derived from bone marrow (BMC) generated clinical studies. Recently published small sized studies have yielded mixed results, leaving the question unanswered.HypothesisWe analyzed data from these studies in a meta‐analysis to investigate if intracoronary stem cell therapy was effective in improving cardiac function.MethodsA total of 7 randomized controlled trials meeting the inclusion criteria were identified by a systematic literature search. Primary endpoint was change in global left ventricular ejection fraction (LVEF) baseline to follow‐up (ranging between 3 to 6 months). The meta‐analysis consisted of 516 patients (BMC group, 256; control group, 260). A 2‐sided α error of less than .05 was considered to be statistically significant (P<.05).ResultsThere were no significant differences in patient characteristics between the BMC treatment and control groups at baseline. Compared to the control group, patients in the BMC treatment group had significantly greater increase in LVEF from baseline to follow‐up (mean difference: 6.108%; SE: 1.753%; 95% confidence interval [CI]: 2.672%− 9.543%; P<.001).ConclusionsThe present meta‐analysis suggests that intracoronary bone marrow stem cell infusion may be effective in improving left ventricular systolic function in patients after acute myocardial infarction. Copyright © 2009 Wiley Periodicals, Inc.

show abstract

Section: Lvef Change Noted In Individual Studiesmentioning

confidence: 79%

Section: Data Synthesis and Analysismentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

See 3 more Smart Citations

Stem Cells Improve Left Ventricular Function in Acute Myocardial Infarction

Singh

Arora

Handa

et al. 2009

Clinical Cardiology

View full text Add to dashboard Cite

show abstract

Adult Bone Marrow–Derived Cells for Cardiac Repair

et al. 2007

View full text Add to dashboard Cite

Background:The results from small clinical studies suggest that therapy with adult bone marrow (BM)derived cells (BMCs) reduces infarct size and improves left ventricular function and perfusion. However, the effects of BMC transplantation in patients with ischemic heart disease remains unclear.Methods: We searched MEDLINE, EMBASE, Science Citation Index, CINAHL (Cumulative Index to Nursing and Allied Health), and the Cochrane Central Register of Controlled Trials (CENTRAL) (through July 2006) for randomized controlled trials and cohort studies of BMC transplantation to treat ischemic heart disease. We conducted a random-effects meta-analysis across eligible studies measuring the same outcomes.Results: Eighteen studies (N = 999 patients) were eligible. The adult BMCs included BM mononuclear cells, BM mesenchymal stem cells, and BM-derived circulat-ing progenitor cells. Compared with controls, BMC transplantation improved left ventricular ejection fraction (pooled difference, 3.66%; 95% confidence interval [CI], 1.93% to 5.40%; PϽ.001); reduced infarct scar size (−5.49%; 95% CI, −9.10% to −1.88%; P=.003); and reduced left ventricular end-systolic volume (−4.80 mL; 95% CI, −8.20 to −1.41 mL; P=.006). Conclusions:The available evidence suggests that BMC transplantation is associated with modest improvements in physiologic and anatomic parameters in patients with both acute myocardial infarction and chronic ischemic heart disease, above and beyond conventional therapy. Therapy with BMCs seems safe. These results support conducting large randomized trials to evaluate the impact of BMC therapy vs the standard of care on patient-important outcomes.

show abstract

Effect of Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells 2 to 3 Weeks Following Acute Myocardial Infarction on Left Ventricular Function

Traverse

Henry

Ellis

et al. 2011

JAMA

386

259

View full text Add to dashboard Cite

Context Clinical trial results suggest that intracoronary delivery of autologous bone marrow mononuclear cells (BMCs) may improve left ventricular (LV) function when administered within the first week following myocardial infarction (MI). However, since a substantial number of patients may not present for early cell delivery, we investigated the efficacy of autologous BMC delivery 2–3 weeks post-MI. Objective To determine if intracoronary delivery of autologous BMCs improves global and regional LV function when delivered 2–3 weeks following first MI. Design, Setting, and Patients LateTIME is a randomized, double-blind, placebo-controlled trial of the National Heart, Lung, and Blood Institute - sponsored Cardiovascular Cell Therapy Research Network (CCTRN) of 87 patients with significant LV dysfunction (LVEF ≤ 45%) following successful primary percutaneous coronary intervention (PCI). Interventions Intracoronary infusion of 150 × 106 autologous BMCs (total nucleated cells) or placebo (2:1 BMC:placebo) was performed within 12 hours of bone marrow aspiration after local automated cell processing. Main Outcome Measures The primary endpoints were changes in global (LVEF) and regional (wall motion) LV function in the infarct and border zone from baseline to 6 months as measured by cardiac MRI at a core lab blinded to treatment assignment Secondary endpoints included changes in LV volumes and infarct size. Results 87 patients were randomized between July 2008 and February 2011: mean age = 57 ± 11 yrs, 83% male. Harvesting, processing, and intracoronary delivery of BMCs in this setting was feasible and safe. The change from baseline to six months in the BMC group, when compared to the placebo group, for LVEF (48.7 to 49.2% vs. 45.3 to 48.8%; Difference = −3.0, 95% CI −7.0 to 0.9), wall motion in the infarct zone (6.2 to 6.5 vs. 4.9 to 5.9 mm; Difference = −0.7, 95% CI −2.8 to 1.3), and wall motion in the border zone (16.0 to 16.6 mm vs. 16.1 to 19.3 mm; Difference = −2.6; 95% CI −6.0 to 0.8) were not statistically significant. There was no significant change in LV volumes and infarct volumes decreased by a similar amount in both groups at 6 months compared to baseline. Conclusions Among patients with MI and LV dysfunction following reperfusion with PCI, intracoronary infusion of autologous BMCs compared to intracoronary placebo infusion, 2–3 weeks after PCI did not improve global or regional function at 6 months.

show abstract

Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial

Cited by 1,176 publications

References 39 publications

Stem Cells Improve Left Ventricular Function in Acute Myocardial Infarction

Stem Cells Improve Left Ventricular Function in Acute Myocardial Infarction

Adult Bone Marrow–Derived Cells for Cardiac Repair

Effect of Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells 2 to 3 Weeks Following Acute Myocardial Infarction on Left Ventricular Function

Contact Info

Product

Resources

About