Work package description

WP1 Project management
The main objectives of this Work Package are:
  • creation and maintenance of an appropriate framework, linking together all the project components and maintaining communications with the Commission;
  • co-ordination at consortium level of the technical and scientific activities of the project;
  • overall legal, contractual, ethical, financial and administrative management of the consortium;
  • preparing, updating and managing the consortium agreement between the participants;
  • co-ordination at consortium level of knowledge management and other innovation-related activities;
  • updating project planning and schedule to reflect progress and changes in project development;
  • acquisition of the Certificate of the Financial Statements by each of the participants.
  • External target monitoring clinical board
WP2 Material Design, Synthesis, Processing, GLP grade
Synthesis of bioactive, selectively porous, bioresorbable scaffolds to be utilized in the regeneration of normal intimal layer of the diseased blood vessels. Two different technical approaches will be explored:
  • Approach A. A preformed SIL to be deployed in the prepared artery. Approach A will be achieved using composite systems made up of natural/synthetic reinforcing elements and ELP.
  • Approach B. In situ shaping of a synthetic scaffold cast into SIL. It will be achieved using a biocompatible and injectable system based on recombinant ELPs
WP3 Material and explant characterization
This WP applies new characterization methods to evaluate physical and chemical properties of the ELPs. To assess the mechanical properties, stability and degradability of the native scaffold as well as the effect of the deployment and in situ mechanical modeling on the properties of the polymers. The main objectives of this Work Package are:
  • Characterization of mechanical, physical and chemical properties of the scaffolds
  • ELP characterization
  • In vitro cultures on the surfaces
  • Dynamic assays of endothelial precursor cells on the surface materials
  • Ex-vivo mechanical testing of the artery after ELP scaffolds implantation
WP4 Material Biological testing (biocompatibility, toxicity)
The principle objective is to characterise the biocompatibility of candidate materials for their suitability for in situ regeneration by measuring phenotypic changes in embedded mononuclear cells and surface attached ECs and EPCs (endothelial progenitor cells), adhesion, mobility, gene and extracellular protein expression, cell proliferation, senescence, necrosis and apoptosis. We will determine the rate of cell repopulation and their functional properties and the expression of adhesion, inflammatory, and chemo attractive molecules by the cells. The functional integrity of the EC-layer will be measured by comparing its thrombogenicity to unseeded functionalized lumen biomaterials. The properties of the functionalized biomaterials will be assessed through adhesion and proliferation of ECs and EPCs. Histochemical analyses and biochemical markers will be used to identify the adherent cells and assess their viability.

WP5 Delivery technology GLP and medical scale and biocompatibility
This WP is committed to the design, optimization and production of specific spray gun for vascular and specific catheters for endovascular application of SIL. In addition, in WP5 we will be analyzing interactions between ELP and deployment devices polymer, to assess potential interaction or activation and explore interface solutions (polymer coating, surface nanotechnology, thermo static)

WP6 In Vivo experiments
The objectives of this WP are to:
  • set up a proper experimental model for evaluate the efficacy
  • Assess inflammatory response and thrombogenicity of scaffold candidates in short-term studies
  • to choose the best performing material and delivery technology from each approach in long-term studies to be further refined and scaled into human vessel size in pig models.
  • Long tern efficacy study in GLP large animals study
WP7 Regulatory, and clinical studies planning, industrialization
Following confirmation of the European regulatory status of the product (presumed to be a medical device), the primary objective of this work package will be to provide regulatory guidance for design and development activities so that the European medical device legal requirements specified in the European Medical Devices Directive (93/42/EEC) are taken into account and compliance with these requirements, as appropriate, is properly documented. The European legislation for medical devices is due to be the subject of a ‘recast’ of the Medical Devices Directive, and this work package will take account of any legislative changes that occur during the project. The objective of this work package is to ensure that any design and development activities and decisions are taken in full knowledge and understanding of any resulting regulatory consequences, so that the design and development can proceed with minimal possibility of rework having to be undertaken because of late recognition of regulatory requirements. The regulatory work conducted throughout the project will also help to ensure that at the end of this phase, sufficient regulatory information and documentation exists to allow the earliest use in human clinical studies.

WP8 Dissemination and Exploitation
Work package 8 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, and the exploitation of the knowledge generated during the project. More specifically the objectives will be:
  • To promote the transfer of technologies developed in the project to industrial companies with particular attention to SMEs.
  • To set the basis for the exploitation of project results through a structured exploitation plan
  • To prevent possible conflicts arising within the consortium concerning the knowledge management and IPR
  • To track relevant innovations during the course of the project such as to facilitate and support the protection of the knowledge generated by the consortium and by individual partners.
  • To publish project results in dedicated high impact journals, provided that all measures to protect the intellectual property are taken
  • To disseminate the project results to targeted meetings, workshops and conferences
  • To attract private investors (e.g. Venture Capitalists, Business Angels, Banks) to finance take-up measures for the exploitation of project results (e.g. start-up/spin-off/joint-ventures creation and promotion of technical/commercial cooperation agreements)