BONAMI (BOne Marrow in Acute Myocardial Infarction)

Acute and Severe Myocardial Infarction Clinical Trial

Official title:

Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200707
• Other study ID #: BRD/03/2-B
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: April 29, 2014
• Start date: December 2004
• Est. completion date: April 2009

Study information

• Verified date: April 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute and Severe Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Intracoronary injection of autologous bone marrow mononuclear cells

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)		after 3 months and 1 year of treatment	No
Secondary	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	No
Secondary	Correlation with biological parameters (hematopoietic stem cell number, etc.) at the time of cell injection