Background: Aggravation of restenosis after percutaneous coronary intervention (PCI) and progression of atherosclerosis has been raised as a potential limitation for granulocyte-colony stimulating factor (G-CSF) based stem cell therapy. We investigated the effect of intracoronary infusion of peripheral blood stem cells (PBSCs) mobilized with G-CSF on segment distal to drug-eluting stent (DES), which are under the direct exposure to infused PBSCs, in patients with AMI. Methods: We randomized 62 patients into cell infusion and control group. All patients underwent PCI with DES. In cell infusion group PBSCs were collected by apheresis after 3 days of G-CSF treatment and infused just distal to DES through the over-the-wire balloon catheter. Until now, 29 patients underwent follow-up angiography. Post-intervention and follow-up intravascular ultrasound (IVUS) images in 5-mm vessel segments immediately distal to DES were analyzed in 15 patients (cell infusion group: n=9, control group: n=6). Results: There was no differences in baseline parameters between the 2 groups. Intracoronary infusion of PBSCs did not aggravate neointimal growth or restenosis in stented segment (late loss: 0.11±0.15 mm vs. 0.13±0.71 mm, p>0.05). In cell infusion group, no significant interval changes at segments distal to DES were found in lumen (7.4±2.0 to 7.6±2.1 mm2, p>0.05), external elastic membrane (EEM) (13.0±3.1 to 13.7±3.3 mm2, p>0.05), and plaque plus media (P&M) areas (5.6±1.9 to 6.2±2.6 mm2, p>0.05). The control group showed no significant changes in lumen (6.5±2.0 to 6.8±1.3 mm2, p>0.05), EEM (13.7±5.0 to 13.9±4.0 mm2, p>0.05), and P&M area (7.2±3.8 to 7.1±3.5 mm2, p>0.05), either. Comparisons between 2 groups showed no significant difference in the change of lumen (4.9±26.7% vs. 10.5±22.9%, p>0.05) and EEM area (6.3±16.6% vs. 4.9±12.6%, p>0.05). There was insignificant increase of P&M area in cell infusion group compared to control group (6.8±10.5% vs. 0.1±6.7%, p=0.13). Conclusions: Intracoronary infusion of PBSCs mobilized with G-CSF does not cause any deleterious effects on the coronary vascular remodeling and de novo progression of atherosclerosis.
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