BONAMI (BOne Marrow in Acute Myocardial Infarction)

Phase 2

Completed

• Conditions: Acute and Severe Myocardial Infarction
• Interventions: Procedure: Intracoronary injection of autologous bone marrow mononuclear cells

• Registration Number: NCT00200707
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-29
• Last Update Posted: 2014-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The treatment group	Intracoronary injection of autologous bone marrow mononuclear cells	Intracoronary Injection of Autologous Bone Marrow Mononuclear C

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection
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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France