Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Collaborators: Else Kröner Fresenius Foundation; Schulz Foundation; Wilhelm Sander Foundation
• Treatments: Lenograstim; Sargramostim

Criteria

Inclusion Criteria:

• ST-elevation acute myocardial infarction (5 days before randomization)

• Successful percutaneous coronary intervention [PCI] (performed within 12 hours from symptom onset)

• Scintigraphic infarct size >5% of left ventricle

• Written informed consent

Exclusion Criteria:

• Age <18 years or >80 years

• Congestive heart failure defined as Killip class >2

• A history of myocardial infarction

• Electrical or hemodynamic instability

• Autoimmune diseases

• Fructose intolerance

• Malignancies

• Incompatibility of filgrastim

• Known or suspected pregnancy