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Laura Brambilla,1 Valeria Frangione,2 Marisa Meloni1 1VitroScreen, in vitro Research Laboratory, Milan, Italy; 2IBSA Institut Biochimique SA, Pambio-Noranco, SwitzerlandCorrespondence: Marisa Meloni, VitroScreen, Via Mosè Bianchi, 103, Milan, 20149, Italy, Tel +39 02 89077608, Email marisa.meloni@vitroscreen.comPurpose: Medical Device Regulation (EU) 2017/745 requires the principal mode of action (MoA) to be demonstrated by experimental data. The MoA of Ialuril® Prefill (combined as HA+CS+CaCl2: sodium hyaluronate 1.6%, sodium chondroitin sulphate 2% w/v and calcium chloride 0.87%) Class III medical device, indicated for intravesical instillation to reduce urinary tract infections, has been evaluated on a 3D reconstructed human bladder epithelium (HBE).Methods: Three experimental designs; i) E. coli strain selection (DSM 103538, DSM 1103) to investigate the HA+CS+CaCl2 properties in modifying bacterial growth in liquid broth (CFU 4h and 24h) at 80%, 50% and 25% concentrations; ii) evaluation of film forming properties on HBE after 15 min exposure by quantifying caffeine permeation across the epithelium; iii) capacity to counteract E. coli adhesion and biofilm formation on colonized HBE by viable counts and ultrastructural analysis by scanning electron microscopy (SEM) using ciprofloxacin as the reference antimicrobial molecule.Results: No significant differences were observed in bacterial viability for both the E. coli strains. HA+CS+CaCl2 reduced caffeine permeation of 51.7% and 38.1% at 1h and 2h, respectively and determined a significant decrease in caffeine permeation rate at both timepoints supporting HA+CS+CaCl2 capacity to firmly adhere to the bladder epithelium creating a physical barrier on the surface. The viable counts in HBE treated tissues then infected with E. coli resulted not different from the negative control suggesting that the device did not inhibit E. coli growth. SEM images showed homogenous product distribution over the HBE surface and confi

Background IgG antibodies against myelin oligodendrocyte glycoprotein (MOG-IgG) define a subset of associated disorders (myelin oligodendrocyte glycoprotein associated disorders (MOGAD)) that can have a relapsing course. However, information on relapse predictors is scarce. The utility of retesting MOG-IgG over time and measuring their titres is uncertain. We aimed to evaluate the clinical relevance of longitudinal MOG-IgG titre measurement to predict relapses in patients with MOGAD. Methods In this retrospective multicentre Italian cohort study, we recruited patients with MOGAD and available longitudinal samples (at least one >3 months after disease onset) and tested them with a live cell-based assay with endpoint titration (1:160 cut-off). Samples were classified as € attack' (within 30 days since a disease attack (n=59, 17%)) and € remission' (≥31 days after attack (n=295, 83%)). Results We included 102 patients with MOGAD (57% adult and 43% paediatric) with a total of 354 samples (83% from remission and 17% from attack). Median titres were higher during attacks (1:1280 vs 1:640, p=0.001). Median onset titres did not correlate with attack-related disability, age or relapses. Remission titres were higher in relapsing patients (p=0.02). When considering the first remission sample available for each patient, titres >1:2560 were predictors of relapsing course in survival (log rank, p<0.001) and multivariate analysis (p<0.001, HR: 10.9, 95% CI 3.4 to 35.2). MOG-IgG seroconversion to negative was associated with a 95% relapse incidence rate reduction (incidence rate ratio: 0.05, p<0.001). Conclusions Persistent MOG-IgG positivity and high remission titres are associated with an increased relapse risk. Longitudinal MOG-IgG titres could be useful to stratify patients to be treated with long term immunosuppression. © 2023 Authors. All rights reserved

Traditional electrochemical techniques, such as linear polarization resistance (Rp), and electrochemical impedance spectroscopy (EIS), cannot be applied to gilded bronzes, as it may not be possible to interpret the results obtained due to the bimetallic nature of the studied material. The measurement of the macrocouple current generated by the gold/bronze galvanic couple can be used as an indicator of degradation processes. Nevertheless, this measurement cannot be performed directly on the original artifacts due to the systematic presence of short-circuits between the two metals. In the present work the use of galvanic sensors is proposed as a possible solution for the monitoring of gilded bronze artefacts. The sensors have been designed to simulate real gilded bronze surfaces in terms of composition and stratigraphy and have proved to be a reliable diagnostic tool for the in situ monitoring of the rates of deterioration of gilded bronze surfaces and to test new conservation treatments. Their set-up and application is reported and their performances discussed.

Traditional electrochemical techniques, such as linear polarization resistance (Rp), and electrochemical impedance spectroscopy (EIS), cannot be applied to gilded bronzes, as it may not be possible to interpret the results obtained due to the bimetallic nature of the studied material. The measurement of the macrocouple current generated by the gold/bronze galvanic couple can be used as an indicator of degradation processes. Nevertheless, this measurement cannot be performed directly on the original artifacts due to the systematic presence of short-circuits between the two metals. In the present work the use of galvanic sensors is proposed as a possible solution for the monitoring of gilded bronze artefacts. The sensors have been designed to simulate real gilded bronze surfaces in terms of composition and stratigraphy and have proved to be a reliable diagnostic tool for the in situ monitoring of the rates of deterioration of gilded bronze surfaces and to test new conservation treatments. Their set-up and application is reported and their performances discussed.