SAFETY TESTING IN THE LIFE CYCLE OF NANOTECHNOLOGY-ENABLED MEDICAL TECHNOLOGIES FOR HEALTH.

Informations projet

SAFE-N-MEDTECH

N° de convention de subvention: 814607

DOI 10.3030/814607

Projet clôturé

Date de signature de la CE 5 Mars 2019

Date de début 1 Avril 2019

Date de fin 30 Septembre 2023

Financé au titre de

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials

Coût total € 18 387 395,36

Contribution de l’UE € 14 534 365,88

Coordonné par

FUNDACION VASCA DE INNOVACION E INVESTIGACION SANITARIAS
Spain

Livrables

Documents, reports (15)

Reports of Monitoring and Hub Activities including Open Calls

Report on imapct of the Hub activities including Open Calls

Workshops and Conferences Report

Report on the Workshops and conferences organized/participated by the project

Regulatory roadmap

Roadmap on regulatory requirements for the development of nanoenabled MTs to practical application to comply with new EU regulation and ISO norms

Document ready on best practices

Guidelines on documentaton and protocools for clinical research

Internal Quality Management process documentation

Documentaton to put in place a CEN Workshop Agreement

Association Legal Statutes - second version

Update of D8.2.Association Legal Statutes

Final Communication and Dissemination Summary and Report

Summary of communication and dissemination actions

Catalogue of Services of OITB

Complilation of services offered by the OITB partners

Protocols for safety handling of nano-enabled MTs

Protocols for safe handling of nanomaterials at clinical sites

Report on clinical evaluation services and validation (test-bed report)

Validated complete report including protocols, e-tools and documents to develop future studies and prepare clinical dossiers

Map of producers of nano-enabled MTs and agreements for the future OITB

Report on existing certified production facilities and model agreements for the future OITB

Constitution of the different management bodies

Report on management bodies

Association Legal Statutes

Proposal of statutes for the future legal structure for the OITB

Regulatory and Ethical recommendations for healthcare professionals, authorities, developers and patients

Protocols with recommendations for facilitating the future commercialization and translation into the final users/clinic of nano-enabled MTs in compliance with European regulations.

Assessment of pathways for early access to innovative MTs

Report on the different pathways for early patient access to innovative MTs in a healthcare and market commercialization context

Demonstrators, pilots, prototypes (3)

Training modules

Training modules for researchers and workforce from companies in the different critical steps related to nano-enabled MT development

Database of technology choices for each nano-enabled MT

Repository of different choices and comparators for individual nano-enabled MT

SAFE-N-MEDTECH website

Public webiste stakeholders oriented

Publications

Peer reviewed articles (24)

Nanotechnology-Based Medical Devices for the Treatment of Chronic Skin Lesions: From Research to the Clinic

Auteurs: Ruggeri, M.; Bianchi, E.; Rossi, S.; Vigani, B.; Bonferoni, M.C.; Caramella, C.; Sandri, G.; Ferrari, F. 
Publié dans: Pharmaceutics, 2020, ISSN 1999-4923
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics12090815

Click-Coupling to Electrostatically Grafted Polymers Greatly Improves the Stability of a Continuous Monitoring Sensor with Single-Molecule Resolution

Auteurs: Yu-Ting Lin, Rosan Vermaas, Junhong Yan, Arthur M. de Jong, and Menno W.J. Prins
Publié dans: ACS Sensors, 2021, ISSN 2379-3694
Éditeur: American Chemical Society
DOI: 10.1021/acssensors.1c00564

Electrospun Scaffolds in Periodontal Wound Healing

Auteurs: Budai-Szűcs, M.; Ruggeri, M.; Faccendini, A.; Léber, A.; Rossi, S.; Varga, G.; Bonferoni, M.C.; Vályi, P.; Burián, K.; Csányi, E.; Sandri, G.; Ferrari, F. 
Publié dans: Polymers, 2021, ISSN 2073-4360
Éditeur: Multidisciplinary Digital Publishing Institute
DOI: 10.3390/polym13020307

Towards FAIR Nanosafety Data

Auteurs: N. Jeliazkova […], A. Botea-Petcu, D. Gheorghe, R. Sandu, A. Precupas, S. Tanasescu et al
Publié dans: Nature Nanotechnology, 2021, ISSN 1748-3387
Éditeur: Nature Publishing Group
DOI: 10.1038/s41565-021-00911-6

Integrated sampling-and-sensing using microdialysis and Biosensing by Particle Motion for continuous cortisol monitoring

Auteurs: L. van Smeden et al.
Publié dans: Sensors & Diagnostics, 2023, ISSN 2635-0998
Éditeur: Royal Society of Chemistry
DOI: 10.1039/d3sd00185g

Innovative Strategies in Tendon Tissue Engineering

Auteurs: Bianchi, E.; Ruggeri, M.; Rossi, S.; Vigani, B.; Miele, D.; Bonferoni, M.C.; Sandri, G.; Ferrari, F.
Publié dans: Pharmaceutics, 2021, ISSN 1999-4923
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics13010089

Continuous monitoring of TNF-α at picomolar concentrations using biosensing by particle motion

Auteurs: A.D. Buskermolen et al.
Publié dans: Biosensors Bioelectronics, 2024, ISSN 0956-5663
Éditeur: Pergamon Press Ltd.

Exposure of human immune cells, to the antiretrovirals efavirenz and lopinavir, leads to lower glucose uptake and altered bioenergetic cell profiles through interactions with SLC2A1

Auteurs: Beth Heaton, Neill Liptrott
Publié dans: Biomedicine and Pharmacotherapy, 2022, ISSN 0753-3322
Éditeur: Elsevier Masson
DOI: 10.1016/j.biopha.2022.112999

Sensing Methodology for the Rapid Monitoring of Biomolecules at Low Concentrations over Long Time Spans

Auteurs: Rafiq M. Lubken, Max H. Bergkamp, Arthur M. de Jong, and Menno W. J. Prins
Publié dans: ACS Sensors, 2021, ISSN 2379-3694
Éditeur: American Chemical Society
DOI: 10.1021/acssensors.1c01991

Smart Device for Biologically Enhanced Functional Regeneration of Osteo–Tendon Interface

Auteurs: Angela Faccendini; Eleonora Bianchi; Marco Ruggeri; Barbara Vigani; Cesare Perotti; Francesco Claudio Pavesi; Laura Caliogna; Francesca Natali; Elena Del Favero; Laura Cantù; Franca Ferrari; Silvia Rossi; Giuseppina Sandri
Publié dans: Pharmaceutics; Volume 13; Numéro 12; Pages: 1996, Numéro 8, 2021, ISSN 1999-4923
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics13121996

Halloysite- and Montmorillonite-Loaded Scaffolds as Enhancers of Chronic Wound Healing

Auteurs: Sandri, Giuseppina; Faccendini, Angela; Longo, Marysol; Ruggeri, Marco; Rossi, Silvia; Bonferoni, Maria Cristina; Miele, Dalila; Prina-Mello, Adriele; Aguzzi, Carola; Viseras, Cesar; Ferrari, Franca
Publié dans: Pharmaceutics, Numéro 11, 2020, ISSN 1999-4923
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics12020179

Reversible immunosensor for the continuous monitoring of cortisol in blood plasma sampled with microdialysis

Auteurs: L. van Smeden et al.
Publié dans: ACS Sensors, 2022, ISSN 2379-3694
Éditeur: American Chemical Society
DOI: 10.1021/acssensors.2c01358

Surface charge of supramolecular nanosystems for in vivo biodistribution: a microSPECT/CT imaging study

Auteurs: Ling Ding, Zhenbin Lyu, Beatrice Louis, Aura Tintaru, Erik Laurini, Domenico Marson, Mengjie Zhang, Wanxuan Shao, Yifan Jiang, Ahlem Bouhlel, Laure Balasse, Philippe Garrigue, Eric Mas, Suzanne Giorgio, Yuanyu Huang, Sabrina Pricl, Benjamin Guillet, Ling Peng
Publié dans: Small, Numéro 16, 2020, Page(s) 2003290, ISSN 1613-6810
Éditeur: Wiley - V C H Verlag GmbbH & Co.
DOI: 10.1002/smll.202003290

Maltodextrin-amino acids electrospun scaffolds cross-linked with Maillard-type reaction for skin tissue engineering

Auteurs: Marco Ruggeri; Eleonora Bianchi; Silvia Rossi; Cinzia Boselli; Antonia Icaro Cornaglia; Lorenzo Malavasi; Riccardo Carzino; Giulia Suarato; Rita Sánchez-Espejo; Athanassia Athanassiou; Cesar Viseras; Franca Ferrari; Giuseppina Sandri
Publié dans: Biomaterials Advances, Numéro 7, 2022, ISSN 2772-9508
Éditeur: Elsevier
DOI: 10.1016/j.msec.2021.112593

Thermodynamic parameters at bio/nano interface and nanomaterial toxicity: A case study on BSA interaction with ZnO, SiO2 and TiO2

Auteurs: A.Precupaş, D. Gheorghe, A. Botea-Petcu, A.R. Leonties, R. Sandu, V.T. Popa, E. Mariussen, N. El Yamani, E. Rundén-Pran, V. Dumit, Y. Xue, M. Cimpan, M. Dusinska, A. Haase, S. Tănăsescu
Publié dans: Chemical Research in Toxicology, 2020, Page(s) 2064 - 2067, ISSN 0893-228X
Éditeur: American Chemical Society
DOI: 10.1021/acs.chemrestox.9b00468

Real-time continuous monitoring of dynamic concentration profiles studied with biosensing by particle motion

Auteurs: M.H. Bergkamp et al.
Publié dans: Lab on a Chip, 2023, ISSN 2046-2069
Éditeur: Royal Society of Chemistry
DOI: 10.1039/d3lc00410d

Real-Time Monitoring of Biomolecules: Dynamic Response Limits of Affinity-Based Sensors

Auteurs: Rafiq M. Lubken, Arthur M. de Jong, and Menno W. J. Prins
Publié dans: ACS Sensors, 2022, ISSN 2379-3694
Éditeur: American Chemical Society
DOI: 10.1021/acssensors.1c02307

Norfloxacin-Loaded Electrospun Scaffolds: Montmorillonite Nanocomposite vs. Free Drug.

Auteurs: Angela Faccendini; Marco Ruggeri; Dalila Miele; Silvia Rossi; Maria Cristina Bonferoni; Carola Aguzzi; Pietro Grisoli; César Viseras; Barbara Vigani; Giuseppina Sandri; Fraanca Ferrari
Publié dans: Pharmaceutics, Numéro 4, 2020, ISSN 1999-4923
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/pharmaceutics12040325

Sandwich immunosensor based on particle motion: how do reactant concentrations and reaction pathways determine the time-dependent response of the sensor?

Auteurs: C.M.S. Michielsen et al
Publié dans: ACS Sensors, 2023, ISSN 2379-3694
Éditeur: American Chemical Society

Continuous Small-Molecule Monitoring with a Digital Single-Particle Switch

Auteurs: Junhong Yan, Laura van Smeden, Maarten Merkx, Peter Zijlstra, and Menno W. J. Prins
Publié dans: ACS Sensors, 2020, ISSN 2379-3694
Éditeur: American Chemical Society
DOI: 10.1021/acssensors.0c00220

High-Throughput Single-Molecule Sensors: How Can the Signals Be Analyzed in Real Time for Achieving Real-Time Continuous Biosensing?

Auteurs: M.H. Bergkamp et al.
Publié dans: ACS Sensors, 2023, ISSN 2379-3694
Éditeur: American Chemical Society
DOI: 10.1021/acssensors.3c00245

Real-Time Detection of State Transitions in Stochastic Signals from Biological Systems

Auteurs: Max H. Bergkamp, Leo J. van IJzendoorn, and Menno W.J. Prins
Publié dans: ACS Omega, 2021, ISSN 2470-1343
Éditeur: American Chemical Society
DOI: 10.1021/acsomega.1c02498

Revising protein Corona Characterization; Combining ITC and NanoDSC to Understand the Interaction of Proteins with porous Nanoparticles

Auteurs: A. Balmori, R. Sandu, D. Gheorghe, A. Botea-Petcu, A. Precupas, S. Tanasescu, D. Sánchez-García, S. Borrós
Publié dans: Frontiers in Bioengineering and Biotechnology, 2021, ISSN 2296-4185
Éditeur: Frontiers, under the Creative Commons Attribution licence (CC-BY) Frontiers Media S.A.

Continuous biomarker monitoring with single molecule resolution by measuring free particle motion

Auteurs: Buskermolen, A.D., Lin, YT., van Smeden, L. et al.
Publié dans: Nature Communications, 2022, ISSN 2041-1723
Éditeur: Nature Publishing Group
DOI: 10.1038/s41467-022-33487-3

Other (1)

Early dialogue and early advice frameworks in Health Technology Assessment and health services: a systematic literature review

Auteurs: Lorea Galnares-Cordero, Gaizka Benguria-Arrate, Nora Ibargoyen-Roteta, Iñaki Gutiérrez-Ibarluzea, Ángel del Pozo Pérez, Marta Suárez García, Kelly Rocio Chacón Acevedo, Eduardo Low Padilla, Ilich Hervert de la Hoz Siegler, Claudia Isabel Guevara Pérez
Publié dans: 2020
Éditeur: CRD University of York

Book chapters (1)

Thermodynamic descriptors of the interaction at the bio/nano interface,

Auteurs: S. Tanasescu, D. Gheorghe, A. Precupas, A. Botea-Petcu, R. Sandu, V.T. Popa
Publié dans: Nanomaterials - functional properties and applications, Series Micro- and nanoengineering, Numéro vol. 28, p. 85-97, 2020, 2020, Page(s) 85-87, ISBN 978-973-27-3290-8
Éditeur: Romanian Academy Publisher