Trial | NCT00126100  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sargramostim ...

  • Study Participants

    114
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.
Study Started
Feb 29
2004
Study Completion
Jul 31
2005
Last Update
Nov 26
2007
Estimate

Drug G-CSF Granulocyte-Colony Stimulating Factor

Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.

  • Other names: Neupogen (Filograstim), Granocyte (Lenograstim)

Other Placebo

Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.

1 Experimental

Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.

2 Placebo Comparator

Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days.

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
No Results Posted