Nanoporous silicium for molecular fingerprinting in neurodegenerative disorders
French National Research Agency (ANR)
Funder: French National Research Agency (ANR)Project code: ANR-14-ENM2-0004
Funder Contribution: 372,041 EUR
Curing neurodegenerative diseases such as dementia is a major unmet biomedical objective costing handicap, life expectancy, and approximately €130 billion per year. This positions age-related neurodegenerative diseases as the leading medical and societal challenges faced by EU society. Accessing the brain to decipher pathological targets for therapy is the main bottleneck for molecular and personalized therapy breakthrough as observed now in oncology. Deep brain stimulation (DBS) remains the only non-lesional approach to explore different brain nucleuses in different diseases, thus, offering a unique temporary access to the pathological tissue in vivo, in awaken patients and at earlier stage of disease. Here our project proposes to take advantage of DBS surgery to harvest a molecular imprint from implanted patients. Taking advantage of the unique advantages of nanotechnologies we invented and patented a dedicated device based on nanoporous surfaces directly implemented on the surgical tools for optimal brain tissue harvesting. Our project has the following objectives: (i) complete the preclinical regulatory documentation of the technology, (ii) finalize the industrial GMP process for nanoporous fabrication as well as the final device association (iii) perform a proof-of-concept trial in neurostimulated patients addressing clinical operapility, safety and compatibility with poly-omics investigations. Ethical as well as societal perception will be anticipated. Complete integrated data mining will ensure the quality management of the project, mandatory for CE norm validation. This project will provide the first validation of a new medical procedure “molecular and cellular nanoporous fingerprint” paving the way for targeted therapy in neurodegenerative disease. Israeli, Swedish and French academic groups will work synergistically to ensure a rigorous EU dissemination of nanomedical innovation, also using this project to progress in the field of ethics, societal perception and “nanomedtech” regulation in Europe. The well-established academic/industry partnership of the project will allow accelerating the preclinical and clinical validation of the device, thereby guaranteeing an efficient industrial transfer and medical dissemination for EU patients with neurodegenerative disease._x000D_
Data Management Plans