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

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: G-CSF Granulocyte-Colony Stimulating Factor; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00126100

KKF 10-02

GE IDE No. I01003

KKF 04-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: G-CSF Granulocyte-Colony Stimulating Factor

2

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo