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PS-FP7 (NMP.2013.2.2-1): MARVENE II: Development of an Advanced Therapy Medicinal Product (ATMP) for neural regeneration
| Zusammenfassung | A Spanish university is writing a proposal for a European funded project. The project aims at developing an Advanced Therapy Medicinal Product (ATMP) for neural regeneration i.e., an instrument for the treatment of peripheral nerve diseases and the improvement of the quality of life of people suffering from neurological injuries. The university is looking for seven different partners with different roles, preferably SMEs. |
| Beschreibung | A Spanish university is writing a proposal for a European project funded by the NMP.2013.2.2-1 call (Biomaterials for Advanced Therapies and Medical Devices in the neurological/neuromuscular or cardiovascular fields). The project aims at developing an Advanced Therapy Medicinal Product (ATMP) for neural regeneration i.e., an instrument for the treatment of peripheral nerve diseases and the improvement of the quality of life of people suffering from neurological injuries. Nerve regeneration is a complex biological phenomenon. In the peripheral nervous system (PNS), nerves regenerate spontaneously only when injuries are minor. In humans, axonal regeneration occurs at a rate of about 1 mm/day; thus major injuries (neurotmesis) can take many months to heal with recovery of nerve function. The proposed solution is to use magnetic nanoparticles as the basis for a novel technology designed to drastically reduce this prolonged recovery time. In this way, the project will develop an innovative ATMP composed of: 1. A Biomaterial that includes a nanostructured biomaterial: functional magnetic nanoparticles (MNP) in a biocompatible colloid. 2. A Medical Device: the magnetic field applicator that controls the intensity and direction of the magnetic field. The proposal, MARVENE II is the follow-up of a previous funded project, MARVENE, where some of the general concepts were already proved. |
| Expertise | In order to build a powerful consortium able to perform the different tasks and to reach the objective, the coordinator is looking for the following partners' profiles: Partner 1: - It should have experience in Pharmaceutical Development, drug development and manufacturing of medicinal products under GMPs (good manufacturing practice). It should be advisable to also have experience in analytical and microbiological Control, as well as quality control of products. - Role in the project: It will make the MNPs' synthesis, the functionalization with fluorescent molecules and it will work out the neurotrophic factor (getting input from academic partners). It will also produce the Batches for pre-Clinical Studies. In addition, he will optimize the chemistry Process, performing the Scale Up & validation of the process. Partner 2: - Expertise: It should have experience in In vitro toxicity - Role in the project: It will be in charge of determination of Blood distribution, EC50, and protein binding. It will also take care of CYP (Cytochrome P450 ) interactions and interaction with the immune-system Partner 3: - Expertise: It should have experience in In vivo toxicity (mice) - Role in the project: It will be in charge of establishing upper and lower limit doses for acute toxicity in mice, sub-acute toxicity in animals and chronic toxicity in animals. It will also establish a 'no observable effect level' (NOEL), as well as characterizing dose-response relationships following repeated doses and identifying and characterizing specific organs affected after repeated administration. Partner 4: - Expertise: It should have experience in Clinical-grade Magnetic Field application. - Role in the project: It will define the requirements for the magnetic field profile. It will also construct both an in vitro applicator and an in vivo applicator. Partner 5: - Expertise: Pharmacokinetics (PK) of drugs and bio-distribution studies in mice. - Role in the project: At different times, it will monitor the presence of the f-MNPs or its metabolites in different organs. Partner 6: - Experience in mouse models of peripheral nerve disease - Role in the project: It will perform In vivo validation of the capability of f-MNPs to promote and enhance peripheral nerve regeneration (in collaboration with academy) Partner 7: - Experience in preclinical regulatory affairs - Role in the project: It will develop the required documents and it will support the decision making process in order to put the generated biomaterial in an optimal position to enter a clinical trial in humans. The concept has already been proved in a model of PC12 cell line in the framework of MARVENE project (2008-2012), funded by NanoSciE+. The aim of this proposal is to make its outcome closer to market uptake. Currently, the consortium includes companies and universities from Spain and Italy. |
| Entwicklungsstand | Proposal under Development |
| Organisationstyp | SME (<250 Employees) |