Title

Nanostructured biomimetic bioprostheses for the regeneration of chronic spinal cord injuries (I24I20000100003)


Description

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 fibers require the use of proper substrates to favor 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, ie amenable to 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.


Objectives and Results

The empty hand of the project is to develop all the required pre-clinical research of a novel bioabsorbable bioprosthesis based on SAPs that support its nervous effective and safe use for a significant functional 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 Aragon

Julian Pardo


Financing Agency

Project carried out with the financial contribution of INAIL (BRIC 2019 - call)

Total Project Budget: €680.000
INAIL financing: €399.000


Coordinator

Fondazione di Religione e di Culto “Casa Sollievo della Sofferenza” (Italy)


Be a partner

Aragón Health Research Institute Foundation, (Spain)

CIUSSS NÎM (Canada)


Duration

09/11/2020 – 09/05/2023 (Extended, 30 months)


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