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

Nantes University Hospital1 site in 1 country101 target enrollmentDecember 2004

ConditionsAcute and Severe Myocardial Infarction

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Acute and Severe Myocardial Infarction
Sponsor: Nantes University Hospital
Enrollment: 101
Locations: 1
Primary Endpoint: Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

April 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year)

Time Frame: after 3 months and 1 year of treatment

Secondary Outcomes

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)