Review Article

Phases I–III Clinical Trials Using Adult Stem Cells

Table 2

Randomized clinical trials with granulocyte colony-stimulating factor in patients with acute myocardial infarction (subcutaneous).

Trial (year)nDoseTiming after AMI (PCI)FollowupComments

Valgimigli [28] (2005)205 μg/kg × 4 d1 dNo change LVEF at 6 mLVEF by SPECT
FIRSTLINE-AMI [16] (2005)5010 μg/kg × 6 d90 minImproved LVEF at 4 mLVEF by echocardiography
REVIVAL-2 [29] (2006)11410 μg/kg × 5 d5 dNo change LVEF at 5 mLVEF by MRI
STEMMI [30] (2006)7810 μg/kg × 6 d28 hNo change LVEF at 6 mLVEF by echocardiography and MRI
G-CSF-STEMI [31] (2006)4410 μg/kg × 5 d35 hNo change LVEF at 3 mLVEF by MRI
Ellis [32] (2006)185 μg/kg × 5 d (low d), 10 μg/kg × 5 d (high d)<30 hImproved LVEF at 30 dLVEF by echocardiography
RIGENERA [17] (2007)4110 μg/kg × 5 d5 dImproved LVEF at 6 mLVEF by echocardiography
Takano [18] (2007)402,5 μg/kg × 5 d1 dImproved LVEF at 6 mLVEF by SPECT
MAGIC [19] (2004)*2710 μg/kg × 4 d; PBC: 1 × 1091 dNo change LVEF at 6 mLVEF by SPECT
MAGIC 3-DES [20] (2006)*5010 μg/kg × 3 d; PBC: 2 × 1091 dImproved LVEF at 6 mLVEF by MRI

*MAGIC trials used a combination of indirect mobilization (G-CSF) and direct intracoronary injection of peripheral blood cells (PBC); LVEF: left ventricular ejection fraction; SPECT: single-photon emission computed tomography; MRI: magnetic resonance imaging.