Development of Functionalised Cell Seeded Bioartificial Organ for Transplantation in Nerve Repair
|Title||Development of Functionalised Cell Seeded Bioartificial Organ for Transplantation in Nerve Repair|
|Sponsor||European Union's Seventh Framework Programme (FP7)|
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 SMEs have veto rights on commercial route for exploitation. An extensive business plan outlining detailed valorisation plan is presented.