Researchers from the University of Medicine and Health Sciences RCSI, AMBER, the SFI Research Center for Advanced Materials and Bioengineering Research, and leading global medical technology company Integra LifeSciences, announced in the review a new breakthrough for nerve repair therapies based on the body’s own processes Matrix Biology.
The preclinical study has shown that the use of extracellular matrix (ECM) promotes better regeneration of nerve fibers across large nerve defects without requiring the application of additional cells or growth factors. In these preclinical trials, the team’s new ECM-loaded medical device, known as a “nerve guidance conduit,” was shown to promote enhanced recovery responses eight weeks after repair of traumatic nerve lacerations. with substantial tissue loss.
The research team found that by refining the combination and ratio of ECM proteins and loading them into the nerve guidance conduit, it was possible to support increased pro-repair inflammation, increased density blood vessels and increased density of regenerating nerves, all as compared to standard of care. By mimicking the body’s nerve repair processes, this new approach may eliminate the need for stem cells and additional drug therapies.
Peripheral nerve injury is a major clinical problem and is known to affect over 5 million people worldwide each year, leaving those with loss of motor or sensory function to muscle or skin. Current therapies to repair nerve damage involve transplanting patients’ healthy nerves to repair the damage or implanting an artificial nerve guide conduit. The team’s new, patented approach to nerve repair has been shown to increase the density of regenerating long nerve structures, called axons, and generate a large increase in blood vessel density to better support regenerating tissue.
Commenting on the results, the lead authors, Drs. Alan Hibbitts and Zuzana Kočí of the Tissue Engineering Research Group based at RCSI’s Department of Anatomy and Regenerative Medicine, and AMBER, said:
“In our laboratory trials, we found that at eight weeks post-implantation, our nerve guidance conduit had successfully improved the prognosis for nerve regeneration and repair compared to the current clinical gold standard. Our conduit supported clear improvements in nerve repair and blood vessel formation and, more importantly, we saw that we could extend it to address very large nerve defects in our preclinical studies.
Regarding the success of this study, Professor Fergal O’Brien, Principal Investigator of the project and Professor of Bioengineering and Regenerative Medicine, Head of the Tissue Engineering Research Group at RCSI and Deputy Director of AMBER, said that the partnership between RCSI, AMBER and Integra LifeSciences was essential to ensure clinical relevance and a lab-to-patient pathway.
“In collaboration with Integra’s chief scientist, Dr. Simon Archibald, the research had a clear objective: to create a device based on scientific excellence with improved results that would translate well to regulatory evaluation, within the framework of clinical and, ultimately, on the patients. This offers a more direct route to market and therefore the potential for a faster real impact on improving the quality of life of patients.
Dr. Simon Archibald, Chief Scientist at Integra LifeSciences, added: “We have partnered with Professor Fergal O’Brien and his team at RCSI to innovate new solutions in regenerative medicine since 2005, and during that time, we rapidly accelerated the development and translation of new biomaterials. We are excited about the future potential of this iterative innovation to address long gap nerve repair, building on our current leading clinical materials for short gap nerve repairs. Placing Integra at the heart of research enables us to bring our expertise to the heart of the scientific process and identify clinically relevant solutions based on cutting-edge science, to improve patient outcomes and the most effective pathway for laboratory in the clinical setting.
Detailing his teams’ plans, Professor O’Brien said: “Our new ECM-enhanced nerve guidance conduits are part of my team’s ongoing research to treat long peripheral nerve defects in partnership with Integra LifeSciences. The results of this project will address the increasingly difficult distances of nerve defects with the ambition to alleviate the current clinical reliance on grafted nerves and move into the next phase of preclinical trials. Our partnership with Integra LifeSciences has been essential to this process, and we look forward to an ambitious program of work that will advance continued improved treatments for injuries and nerve damage.
Reference: Hibbitts AJ, Koci Z, Kneafsey S, et al. Multifactorial engineering of nerve guidance conduits improves outcomes in inflammation, angiogenesis, and repair of large nerve defects. Matrix biology. Published online January 13, 2022. doi:10.1016/j.matbio.2022.01.002
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