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Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial.

Jérôme Roncalli 1, 2 Frédéric Mouquet 3 Christophe Piot 4 Jean-Noel Trochu 5 Philippe Le Corvoisier 6, 7 Yannick Neuder 8 Thierry Le Tourneau 3, 5 Denis Agostini 9 Virginia Gaxotte 10 Catherine Sportouch 4 Michel Galinier 1, 2 Dominique Crochet 5 Emmanuel Teiger 6, 7 Marie-Jeanne Richard 11 Anne-Sophie Polge 3 Jean-Paul Beregi 10 Alain Manrique 12 Didier Carrie 1, 2 Sophie Susen 13 Bernard Klein 4 Angelo Parini 2 Guillaume Lamirault 5 Pierre Croisille 14 Hélène Rouard 15 Philippe Bourin 16 Jean-Michel Nguyen 17 Béatrice Delasalle 5 Gérald Vanzetto 8 Eric van Belle 3 Patricia Lemarchand 5, *
* Corresponding author
1 Fédération de Cardiologie
2 I2MR - Institut de médecine moléculaire de Rangueil
3 Interface sang vaisseaux et réparation cardiovasculaire
4 IRB - Institut de recherche en biothérapie
5 Institut du thorax
6 IMRB - Institut Mondor de Recherche Biomédicale
7 CIC - CHU Henri Mondor
8 Radiopharmaceutiques biocliniques
9 Groupe coeur et ischémie
10 Therapies Interventionnelles Assistees Par l'Image et la Simulation
11 INSERM U823 - Institut d'oncologie/développement Albert Bonniot de Grenoble
12 Cyceron - GIP Cyceron
13 Pôle de Pathologie cardiologie-vasculaire
14 RMN et optique : De la mesure au biomarqueur
CREATIS - Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé
15 Unité Mixte de Thérapie Cellulaire [Grenoble]
16 EFS - Laboratoire de thérapie cellulaire
17 PIMESP
Abstract : AIMS: Intracoronary administration of autologous bone marrow cells (BMCs) leads to a modest improvement in cardiac function, but the effect on myocardial viability is unknown. The aim of this randomized multicentre study was to evaluate the effect of BMC therapy on myocardial viability in patients with decreased left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI) and to identify predictive factors for improvement of myocardial viability. METHODS AND RESULTS: One hundred and one patients with AMI and successful reperfusion, LVEF ≤45%, and decreased myocardial viability (resting Tl201-SPECT) were randomized to either a control group (n = 49) or a BMC group (n = 52). Primary endpoint was improvement of myocardial viability 3 months after AMI. Baseline mean LVEF measured by radionuclide angiography was 36.3 ± 6.9%. Bone marrow cell infusion was performed 9.3 ± 1.7 days after AMI. Myocardial viability improved in 16/47 (34%) patients in the BMC group compared with 7/43 (16%) in the control group (P = 0.06). The number of non-viable segments becoming viable was 0.8 ± 1.1 in the control group and 1.2 ± 1.5 in the BMC group (P = 0.13). Multivariate analysis including major post-AMI prognostic factors showed a significant improvement of myocardial viability in BMC vs. control group (P = 0.03). Moreover, a significant adverse role for active smoking (P = 0.04) and a positive trend for microvascular obstruction (P = 0.07) were observed. CONCLUSION: Intracoronary autologous BMC administration to patients with decreased LVEF after AMI was associated with improvement of myocardial viability in multivariate-but not in univariate-analysis. A large multicentre international trial is warranted to further document the efficacy of cardiac cell therapy and better define a group of patients that will benefit from this therapy. Clinical Trial Registration Information: URL: http://www.clinicaltrials.gov. Unique identifier NCT00200707.
Keywords : Myocardial infarction Cells Smoking
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CNRS | INSA-LYON | U823 | IMRB | UNIV-NANTES | CEA | UPEC | UPEC-UPEM | UGA | COMUE-NORMANDIE | UNIV-MONTPELLIER | UNIV-LYON1 | HCL | UNIV-ST-ETIENNE | CREATIS | UNICAEN | THORAX-UMR | INSA-GROUPE | UNIV-TLSE3 | UDL

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Jérôme Roncalli, Frédéric Mouquet, Christophe Piot, Jean-Noel Trochu, Philippe Le Corvoisier, et al.. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial.. European Heart Journal, Oxford University Press (OUP): Policy B, 2011, 32 (14), pp.1748-57. ⟨10.1093/eurheartj/ehq455⟩. ⟨inserm-00543644⟩

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