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

A Randomized Clinical Trial of Stem Cell Mobilization by Granulocyte-Colony-Stimulating Factor in Patients With Acute Myocardial Infarction. Regenerate Vital Myocardium by Vigorous Activation of Bone Marrow Stem Cells (REVIVAL-2) Trial

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.

Experimental studies and early-phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem cells that are available cells for myocardial regeneration.

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