Nanomed3D lead product for human therapeutic purposes, NanoSpinal, is a bioresorbable prosthesis designed to regenerate nervous tissue following chronic spinal cord injury. It is entirely synthetic and biomimetic, and constitutes the paramount result of different nanotech-based techniques.
Approximately 0.4% (1,275,000) of the US population suffers paralysis caused by spinal cord injury. The average age of those suffering spinal cord injury is 48, representing a major impact on the wellbeing of families and a massive health care burden. In fact, each year, paralysis and spinal cord injuries cost the health care system billions of dollars.
While pre-clinical research is thriving with new therapies for spinal cord injury no clinical treatment is available yet for the regeneration of injured neural tracts and the tested therapies showed a limited improvement in patients.
In particular, no significant results have been obtained so far in chronic injuries. Indeed, chronic spinal cord injuries, regarding the vast majority of current patients, are a more demanding target than acute injuries as:
the acute injury enlarges over time until stabilized in its chronic state;
the chronic injury mainly consists of a cyst surrounded by a gliotic scar, both representing a biophysical barrier to nervous regeneration;
further degeneration continues over time distally to the lesion toward the target muscles.
In particular, no significant results have been obtained so far in chronic injuries. Indeed, chronic spinal cord injuries, regarding the vast majority of current patients, are a more demanding target than acute injuries as:
the acute injury enlarges over time until stabilized in its chronic state;
the chronic injury mainly consists of a cyst surrounded by a gliotic scar, both representing a biophysical barrier to nervous regeneration;
further degeneration continues over time distally to the lesion toward the target muscles.
A Peptidic Scaffold for the Regeneration of Chronic Spinal Cord Injuries
Nanomed3D lead product for human therapeutic purposes, NanoSpinal, is a surgical medical device aiming at helping the body regenerate nervous tissue following chronic spinal cord injury. NanoSpinal is a combination of electrospun fibrous microtubes and hydrogels made of Nanomed3D patented SAPs. These tubes are surgically implanted in the spinal cord at the site of damage. The scaffold proposed and tested by Nanomed3D comprises electrospun microchannels, providing spatial guidance to the regenerating nervous fibers, and multi-functionalized SAPs, attracting nervous cells through multiple functional motifs and nanostructured microenvironments, placed along the longitudinal cord axis in order to fill the site of injury.
NanoSpinal guides the formation of new nerve fibers, or axons, across this fluid‐filled space.
These tubes provide the reference points for the cells, and tissue starts to build up. NanoSpinal is a finely tuned bioabsorbable peptidic scaffold that remains in situ during nervous tissue regeneration and will be slowly bioabsorbed by the host body.
Functional Regeneration
NanoSpinal caused compelling results in animal models of chronic spinal cord injuries: extended aligned axonal growth, neurons re-growth and myelination protruding the implanted device, a regain of functionality of the lower limbs months after surgery. Behavioral data were also confirmed by electrophysiological tests. New blood vessels formation and nervous ECM-like deposition along the direction of the implanted guidance channels were also detected.
Pre-clinical data have shown that customized nanostructured SAPs and electrospun tubes foster the longitudinal growth and differentiation of the body’s own cells to form new, functional nervous tissue along the spinal cord axis, opening the door to a potential efficacious therapy.
Functional Regeneration
NanoSpinal caused compelling results in animal models of chronic spinal cord injuries: extended aligned axonal growth, neurons re-growth and myelination protruding the implanted device, a regain of functionality of the lower limbs months after surgery. Behavioral data were also confirmed by electrophysiological tests. New blood vessels formation and nervous ECM-like deposition along the direction of the implanted guidance channels were also detected.
Pre-clinical data have shown that customized nanostructured SAPs and electrospun tubes foster the longitudinal growth and differentiation of the body’s own cells to form new, functional nervous tissue along the spinal cord axis, opening the door to a potential efficacious therapy.
The success of this treatment in the most challenging animal model of spinal cord injury is the result of two key factors, the regeneration of the body’s own tissues by providing tuned microenvironments with the integration of precise functionalized peptide motifs and the holistic approach which allows the body to regenerate all of the necessary elements of functioning nervous tissue including vascularization.
Perspective
NanoSpinal pre-clinical results constitute the forefront of the regenerative therapies for chronic spinal cord injuries. As such, Nanomed3D aims to finalize all pre-clinical experiments and begin a Phase I Clinical Trial of NanoSpinal in the near future.