Workpackages description

WP1: ISP design, synthesis and in vitro test
The objectives of this WP is to design, synthesize and test in vitro, the immunosuppressive peptides that will be then engineered onto β cells. The “mice” program will follow soon after and will be driven by progress in developing of the “human” ISPs testing. In vitro immunology tests will be performed aiming to show suppression of allo-reaction and xeno-reaction with ISP added in culture. In sequence the main objectives are:
i) human ISP design;
ii) ISP human synthesis;
iii) ISP human in vitro test,
iv) ISP mouse analogue design;
v) mouse ISP synthesis,
vi) ISP mouse in vitro test;
vii) ISP human in xenogenic (pig) model.

WP2: Beta cell nano-engineering
The main goal of the present WP is the assembly of:
i) biofunctional dendrons design
ii)Synthgesis of bi-functional dendrons able to recognize and bind the cell glycocalyx and to present ISP peptide sequence to the surrounding environment
iii) β-cell nano-engineering to functionalise the surface of b cells (human and murine) with the bi-functional Dendron and to assess the efficiency of binding of the dendrons to the glycocalyx under cell culturing conditions
iv) Demonstration of self-suppression induced by eng.βcell in MLR Wp3: BioCHIP construction and in vitro experimentation The objectives of the presenta

WP 3: BioCHIP construction and in vitro experimentation
The main objectives of thies WP are:
i) to synthesised optimized and scaled-up batches of chitosan nanobeads
ii) to upload the beads with VEGF
iii) to integrate the VEGF-laden nanobeads into Biochips
iv) to optimise human and animal Biochips

WP4: In vivo experimentation
This WP aims at implementing the functionality in NOD-scid diabetic mice 4.2 to test immune protection of nano-engineered β-cells in STZ-diabetic mice and precent rejection of allogenic bioCHIPs in STZ-diabetic mice.

WP5: Biocompatibility, safety and toxicology
The objectives of this WP are:
i) Biocompatibility testing of immunosuppressive peptides (ISPs) and BioCHIP components, and selection of materials with best performance criteria in murine, human and porcine systems
ii) Evaluate toxicity of ISPs and BioCHIPs in formats optimized for functional response, based upon measures of cytotoxicity, inflammatory reaction and immune response and fibrosis induction, using allogenic cell-based systems
iii) Ranking of ISP and BioCHIP formulations to inform selection of materials for subsequent, detailed evaluation in murine, human and porcine models of islet replacement

WP6: Medical Grade Scale Up
The objectives of the preset WP is to set the basis for the transfer of the concept proposed by the project to the operational phase in support of future clinical applications.

WP7: Dissemination and Exploitation
Work package 7 will be dealing with all aspects connected to the knowledge management of the project, including the dissemination of the results to the scientific world, to industrial stakeholders and to a wider community of potential end users, the exploitation of the knowledge generated during the project and the monitoring of regulatory issues. More specifically the objectives will be: i) To promote the transfer of technologies developed in the project to industrial partners; ii) To set the basis for the exploitation of project results through a structured exploitation plan; iii) To prevent possible conflicts arising within the consortium concerning the knowledge management and IPR; iv) To track relevant innovations during the course of the project to facilitate and support the protection of the knowledge generated by the consortium and by individual partners; v) To publish project results in dedicated high impact journals, provided that all measures to protect the intellectual property are taken vi) To disseminate the project results to targeted meetings, workshops and conferences; vii) To attract the interest of investors and liase with life sciences professionals possibly interest in creating joint ventures to face future clinical trials viii) Align the project exploitation strategy with the objectives

WP8: Project management
The project management will aim at:
i) Ensuring effective co-ordination and collaboration among partners within the project and monitoring progress thus pursuing project success
ii) Ensuring the fulfilment of the overall goals of the project, within the time and budget constraints
iii) Providing a common interface towards the external, by representing the entire Consortium towards the Commission, the representatives of other projects, and in the dissemination events
iv) Guaranteeing technological and methodological homogeneity in project development and in the achievement of the expected results
v) Ensuring that any deviations from the plans are resolved involving the SC, as necessary
vi) Organizing effective technical, administrative and review meetings, as appropriate
vii) Maintaining direct liaison with the EC
viii) Maintaining accurate records of cost and effort reports by partners
ix) Co-ordinating the preparation and distribution of all reports
x) Ensuring effective co-ordination between the consortium and external organisations

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