Author + information
Our NANOM FIM trial (NCT01270139) documented per cent atheroma volume reduction up to 30.7%. This subanalysis conducted to examine cytotoxicity of nanoparticles (NP) in red blood cells (RBC).
The observational three arms NANOM FIM trial assessed the safety and feasibility of plasmonic photothermal therapy (PPTT) with silica-gold NP. The surface of RBC was tested (n=108) ex vivo with atomic force microscopy (AFM).
The analysis of AFM 2D- and 3D-images of RBC demonstrates growing number of domains (from 0.34 to 6.12 in 0.1 g/L NP blood vs from 0.22 to 1.12 per cell in blood with saline respectively, p<0.05) during first 72 hours after infusion of NP without hemolysis. The domains on the RBC membrane manifested as figures of endocytosis (E) in all cases and direct penetration (DP) in 16.7% cells. These grain structures appear due to perturbation of the macromolecular complex contributed to remodeling of the RBC surface as a part of the inward vesiculation process with the certain concentration-dependent effect. No significant differences in the level of any biochemical markers or signs of nanotoxicity at the target organs (blood, heart, kidney, spleen, brain, etc.) at the 12-month follow-up were found in patients.
The NANOM-FIM trial demonstrates high safety of the selected nanotechnologies. The screening topological AFM investigation of the RBC membranes holds a potential to be used as a routine method for express assessment of nanotoxicity in real clinical practice.