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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00126100

Enrollment

114

Registered

2005-08-02

Start date

2004-02-29

Completion date

2005-07-31

Last updated

2007-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Stem Cells

Brief 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.

Detailed 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.

Interventions

DRUGG-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.

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Reduction of infarct size (measured by Tc-sestamibi scintigraphy)	measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months

Secondary

Measure	Time frame
Left ventricular ejection fraction	Left ventricular ejection fraction
Incidence of angiographic restenosis	6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026