Background: Our previous bench studies PLASMONICS and NANOM First-in-Man trial documented TAV reduction up to unprecedented 79.4 and 60.3 mm3 respectively with high level of safety and feasibility. Methods: The completed randomized two arm (1:1) study (NANOM-PCI) with parallel assignment (n=62) assessed (NCT01436123) the safety and feasibility of the delivery technique for nanoparticles (NP) using micro-injection catheter (with intravascular intramural injection of allogenious stem cells carring NP after MSCT-, IVUS- and OCT-guided mapping of the vessel), and plasmonic photothermal therapy of atherosclerosis combined with stenting (Nano group, n=32) versus stenting with Xience V cage (Stenting group, n=30). The primary outcome was TAV at 12 months. Results: The mean reduction of TAV at 12 months in Nano group was -84.1 mm3 (95% CI: SD 28.3; min -52.4 mm3, max -99.1 mm3; p<0.05) versus +12.4 mm3 in case of stenting (p<0.05 between groups). The analysis of the event-free survival of the ongoing clinical follow-up shows the significantly lower risk of cardiovascular death in Nano group if compare with conventional stenting (93.4% vs 86.7%; p<0.05). Conclusions: Plasmonic resonance-mediated therapy using noble-metal NP associated with significant regression of coronary atherosclerosis.
Journal: TechConnect Briefs
Volume: 3, Nanotechnology 2013: Bio Sensors, Instruments, Medical, Environment and Energy (Volume 3)
Published: May 12, 2013
Pages: 369 - 372
Industry sectors: Advanced Materials & Manufacturing | Medical & Biotech
Topics: Biomaterials, Cancer Nanotechnology