Step by Step will be made by two groups that will work in parallel on the two goals.
Objective 1: The assembly between drugs and polymeric biomaterials will be achieved by physical mixing and/or chemical conjugation and subsequent electrospunning. Devices will be characterized in vitro for the release of active substances, degradation of the material and toxicity, to identify the technological solution that best suits therapeutic goals (constant release over a defined time). The most promising devices will be tested in vitro for biocompatibility and in vivo in the experimental model of spinal cord traumatic lesion to test efficacy on locomotion (primary end-point), lesion volume, histopathology and molecular markers. The most effective release system will be tested in vitro for toxicity, safety in GLP test facility.
Objective 2: A system will be developed, tested and validated clinically on people with spinal cord lesions in the MRI (Montecatone Rehabilitation Institute) for instrumental evaluation: (i) level of autonomy and trunk control; (ii) the kinematic characteristics of the pathway in and out of water. This system will make possible the objective and accurate definition of the level of autonomy and control of the trunk and will allow to perform a thorough gait analysis o in and out of water. The system will be based on non-invasive wearable inertial sensors. Inertial data will be collected and processed by an application developed on a mobile platform (smartphone / tablet), effectively deploying a mobile healthcare platform.