Development of Functionalised Cell Seeded Bioartificial Organ for Transplantation in Nerve Repair
Injuries and degenerative diseases of the central nervous system constitute a bottleneck in medical and surgical practice for which no therapy currently exists. To ensure clinical translation, NeuroGraft is organised in three R&D Work-Packages. NeuroGraft will develop functionalised cell seeded bioartificial organs, specifically spinal cord conduits for transplantation, incorporating a potent immunomodulatory cytokine (IL37) to target the initial inflammatory response to increase the survival and therapeutic efficacy of transplanted mesenchymal cells and the expression of potent neuro-regulatory molecules for enhanced functional nerve regeneration in the central nervous system.
This exciting concept will be realised through the NeuroGraft consortium, consisting of one academic and four industrial partners (all SMEs), across four countries, with distinct synergistic expertise (including regulatory expertise) to develop cell seeded functionalised bioartificial organs as valuable solutions towards spinal cord repair. Regulatory advice is incorporated at an early stage in the development cycle, to facilitate the translation of the novel bioartificial devices developed, to the market in as short a timeframe as possible. The NeuroGraft consortium will validate the safety, efficacy and biodistribution of the functionalised bioartificial organs developed in a pre-clinical model of spinal cord under GLP conditions. Full Quality Assurance reports will be completed towards CE Mark regulatory approval of the medical device for spinal cord repair. These studies will facilitate progression to clinical trials of the technology (post project) and the development of a marketable product within 6 years of the completion of the NeuroGraft project. Intellectual property will be patented ensuring that SME’s have veto rights on commercial route for exploitation. An extensive business plan outlining detailed valorisation plan is presented.
NUIG (Coordinator), Vornia Ltd, Obelis SA, Stemmaters, Biomatech SAS.
NanoPilot will set-up a flexible and adaptable pilot plant operating under GMP for the production of small batches of polymer-based nanopharmaceuticals, which exhibit significant potential in the field of drug-delivery particularly for the design of second-generation nanopharmaceuticals.
The production of innovative nanopharmaceuticals in quantity and quality (GMP) required for them to enter clinical trials remains a challenge. Production cannot easily be implemented in existing manufacturing plants, specialized and optimized for the production of conventional drugs.
In addition, small companies usually do not have the resources to up-scale and implement GMP manufacturing of their potential nanopharmaceutical. This can limit the capacity of these organizations for advancing their research, and as a consequence, slow-down the development of innovative nanopharmaceuticals to treat different diseases.
In this context, it is urgently needed to provide those SMEs with the tools that can help them with the validation of their technologies.
Fundacion Cidetec (Coordinator), NUI Galway, Universidad De Santiago De Compostela, Sylentis SAU, IX-FACTORY GMBH, Chemtrix BV, Mejoran Lab Automation SL, Spinverse OY, Association Pour Le Developpement De L'enseignement Et Des Recherches Aupres Des Universites, Des Centres De Recherche Et Des Entreprises D'aquitaine, Micronit GMBH.
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