BONAMI (BOne Marrow in Acute Myocardial Infarction)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: Acute and Severe Myocardial Infarction

Treatments: Procedure: Intracoronary injection of autologous bone marrow mononuclear cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00200707

BRD/03/2-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

The treatment group

Experimental group

Description:

Intracoronary Injection of Autologous Bone Marrow Mononuclear C

Treatment:

Procedure: Intracoronary injection of autologous bone marrow mononuclear cells

the control group

No Intervention group