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Randomized Controlled Trial
. 2011 Nov 16;306(19):2110-9.
doi: 10.1001/jama.2011.1670. Epub 2011 Nov 14.

Effect of intracoronary delivery of autologous bone marrow mononuclear cells 2 to 3 weeks following acute myocardial infarction on left ventricular function: the LateTIME randomized trial

Jay H Traverse  1 , Timothy D Henry, Stephen G Ellis, Carl J Pepine, James T Willerson, David X M Zhao, John R Forder, Barry J Byrne, Antonis K Hatzopoulos, Marc S Penn, Emerson C Perin, Kenneth W Baran, Jeffrey Chambers, Charles Lambert, Ganesh Raveendran, Daniel I Simon, Douglas E Vaughan, Lara M Simpson, Adrian P Gee, Doris A Taylor, Christopher R Cogle, James D Thomas, Guilherme V Silva, Beth C Jorgenson, Rachel E Olson, Sherry Bowman, Judy Francescon, Carrie Geither, Eileen Handberg, Deirdre X Smith, Sarah Baraniuk, Linda B Piller, Catalin Loghin, David Aguilar, Sara Richman, Claudia Zierold, Judy Bettencourt, Shelly L Sayre, Rachel W Vojvodic, Sonia I Skarlatos, David J Gordon, Ray F Ebert, Minjung Kwak, Lemuel A Moyé, Robert D Simari; Cardiovascular Cell Therapy ResearchNetwork
Collaborators, Affiliations
Randomized Controlled Trial

Effect of intracoronary delivery of autologous bone marrow mononuclear cells 2 to 3 weeks following acute myocardial infarction on left ventricular function: the LateTIME randomized trial

Jay H Traverse et al. JAMA. .

Abstract

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, because a substantial number of patients may not present for early cell delivery, the efficacy of autologous BMC delivery 2 to 3 weeks post-MI warrants investigation.

Objective: To determine if intracoronary delivery of autologous BMCs improves global and regional LV function when delivered 2 to 3 weeks following first MI.

Design, setting, and patients: A randomized, double-blind, placebo-controlled trial (LateTIME) of the National Heart, Lung, and Blood Institute-sponsored Cardiovascular Cell Therapy Research Network of 87 patients with significant LV dysfunction (LV ejection fraction [LVEF] ≤45%) following successful primary percutaneous coronary intervention (PCI) between July 8, 2008, and February 28, 2011.

Interventions: Intracoronary infusion of 150 × 10(6) autologous BMCs (total nucleated cells) or placebo (BMC:placebo, 2:1) was performed within 12 hours of bone marrow aspiration after local automated cell processing.

Main outcome measures: Changes in global (LVEF) and regional (wall motion) LV function in the infarct and border zone between baseline and 6 months, measured by cardiac magnetic resonance imaging. Secondary end points included changes in LV volumes and infarct size.

Results: A total of 87 patients were randomized (mean [SD] age, 57 [11] years; 83% men). Harvesting, processing, and intracoronary delivery of BMCs in this setting was feasible. Change between baseline and 6 months in the BMC group vs placebo for mean LVEF (48.7% to 49.2% vs 45.3% to 48.8%; between-group mean difference, -3.00; 95% CI, -7.05 to 0.95), wall motion in the infarct zone (6.2 to 6.5 mm vs 4.9 to 5.9 mm; between-group mean difference, -0.70; 95% CI, -2.78 to 1.34), and wall motion in the border zone (16.0 to 16.6 mm vs 16.1 to 19.3 mm; between-group mean difference, -2.60; 95% CI, -6.03 to 0.77) were not statistically significant. No significant change in LV volumes and infarct volumes was observed; both groups decreased by a similar amount at 6 months vs baseline.

Conclusion: Among patients with MI and LV dysfunction following reperfusion with PCI, intracoronary infusion of autologous BMCs vs intracoronary placebo infusion, 2 to 3 weeks after PCI, did not improve global or regional function at 6 months.

Trial registration: clinicaltrials.gov Identifier: NCT00684060.

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Figure 1
CONSORT Diagram
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Primary Endpoint Analysis Solid circles represent the means and I-bars represent the confidence intervals.
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