Título
Nanostructured biomimetic bioprostheses for the regeneration of chronic spinal cord injuries (I24I20000100003)
Descripción
Spinal cord injury (SCI) is still an invalidating pathology, mostly as a consequence of an acute traumatic event, burdening patients’ lives and health-care systems. Chronic SCI is characterized by a permanent loss of large amounts of nervous tissue and formation of a gliotic scar constituting a physico-chemical barrier to nervous regeneration. To date, no effective therapeutic approach is available yet for chronic SCI. Human neural stem cells (hNSCs) feature tremendous potential for neuroregenerative therapies in humans but they are ineffective whenever a consistent loss of nervous tissue has occurred, like in chronic SCI. Therapies based on transplanted cells and/or regenerating nervous fibres require the use of proper substrates to favour cell engraftment and host tissue regeneration, which is needed to regenerate the neural-circuitry pre-existing the injury. Self-assembling peptides (SAPs) are synthetic biomaterials (made of natural amino acids) at the forefront of nervous tissue engineering because they are bioabsorbable, highly biocompatible, and biomimetic, i.e. amenable of functionalization with active moieties interacting with cells and proteins. In addition, SAPs provide nanostructured microenvironments morphologically resembling the natural extracellular matrices (ECM). Indeed, SAPs alone or in combination with cell transplants have shown great promise for neuronal regeneration.
Objetivos y Resultados
The main goal of the project is to develop all the required pre-clinical research of a novel bioabsorbable bioprosthesis based on SAPs that support its effective and safe use for a significant functional nervous regeneration in chronic SCI. Main objectives are:
● to produce and standardize SAP-based hydrogels and electrospun microchannels
● to test both safety and therapeutic efficacy of SAPs in both small (rats) and large (minipigs) animal models of chronic SCI
● to assess the benefits of including SAPs to treatments using hNSCs
● to address all medical regulatory aspects of the selected approach (SAP device or combined therapy), aiming at bringing our nanomedicine-based therapy closer to a clinical trial
● to patent the scaffold composition (or the production process), which, if successful, will be subsequently (after the end of the project) carried forward by IRCCS Casa Sollievo della Sofferenza (CSS), capable of acting both as a clinical trial site and a business incubator
● to spread the results of this project, after securing IP, through open access publication, congresses and workshops, to stimulate the involvement of both patients and the research community
IP IIS Aragón
Julián Pardo
Organismo Financiador
Project carried out with the financial contribution of INAIL (BRIC 2019 - call)
Presupuesto total del Proyecto: 680.000 €
Financiación INAIL: 399.000 €
Coordinador
Fondazione di Religione e di Culto “Casa Sollievo della Sofferenza” (Italia)
Socios
Fundación Instituto de Investigación Sanitaria Aragón, (Spain)
CIUSSS NÎM (Canadá)
Duración
09/11/2020 – 09/05/2023 (Prorrogado, 30 meses)