BONAMI (BOne Marrow in Acute Myocardial Infarction)

Conditions

Acute and Severe Myocardial Infarction

Keywords

Cell therapy, bone marrow mononuclear cells, myocardial infarction

Brief summary

Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.

Detailed description

After successful percutaneous coronary intervention (PCI) for acute myocardial infarction, 100 patients are randomly assigned to either a control group (n=50) who receives an optimal medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.

Lamirault G, de Bock E, Sébille V, Delasalle B, Roncalli J, Susen S, Piot C, Trochu JN, Teiger E, Neuder Y, Le Tourneau T, Manrique A, Hardouin JB, Lemarchand P.

2016-07-2012 citations

10.1007/s11136-016-1366-7

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

Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P.

2010-12-02106 citations

10.1093/eurheartj/ehq455

Interventions

PROCEDUREIntracoronary injection of autologous bone marrow mononuclear cells

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* Men or women between 18-75 years. * Acute myocardial infarction * Absence of viability in the infarcted zone and LVEF \<45%.

Exclusion criteria

* History of prior myocardial infarction * Significant stenosis in another coronary territory than the acutely treated vessel

Design outcomes

Primary

Measure	Time frame
Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)	after 3 months and 1 year of treatment

Secondary

Measure	Time frame
Left ventricle ejection fraction (LVEF) evaluated by radionuclide ventriculography, (3 and 12 months) and by echography (1, 3, 6, and 12 months). Segmental EF and myocardial viability evaluated by MRI (3 months)	after 1,3,6 ,12 months of treatment
Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection	—

Countries

France

Outcome results

None listed