Tissue Engineering of the Right Heart Outflow Tract by a Biofunctionalized Bioresorbable Polymeric Valved Tube

The TEH-TUBE Project's Work Programme

In order to ensure efficient and effective management of the TEH-TUBE project, we have organised the body of work into distinct Work Packages, each with associated Deliverables that will contribute towards the results of the project. These Work Packages have their own start and end dates within the lifespan of the project, some of which may run concurrently with others while one Work Package may rely on the successful completion of others with which it is associated. This will allow us to logically compartmentalise the project and ensure successful management and administration and consideration of risks and results on both an individual basis as well as in terms of the project as a whole.

We will also utilise Milestones throughout the project, which form goals that we will be working towards. Successfully reaching project Milestones will ensure that progress is being achieved according to the overall programme of work and that the results of the project will both innovative as well as clinically beneficial.

Work Package 1: Polymer Processing
Lead Partner: UCL
Polymer Configuration via electrospinning and scaffold production.

Work Package 2: Scaffold Design, Testing and Production
Lead Partner: STATICE
Use of computational modelling for scaffold design with optimal parameters, mechanical in vitro testing and valved tube production.

Work Package 3: Cell Culture and Characterisation of Seeded Scaffolds
Lead Partner: APHP
Optimization of the culture and characterization of human and ovine adipose-derived stem cells (ADSC) and for seeding.

Work Package 4: Polymer Biofunctionalization
Lead Partner: HZG
Providing biofunctionalized implants via peptide coupling to electrospun scaffolds, development of multiblock polyester urethane and surface functionalization under GMP conditions.

Work Package 5: In vivo Studies
Lead Partner: APHP
Evaluation of mechanical and biological outcomes of in vivo scaffold studies.

Work Package 6: Pre-clinical Evaluation
Lead Partner: APHP
Obtain preclinical validation of the TEH-tube in order to support future pilot clinical trials.

Work Package 7: Quality Assurance and Regulatory Affairs
Lead Partner: C3BS
Establish manufacturing processes and scale-up GMP production within the regulatory framework (ISO 13845).

Work Package 8: Clinical-grade Manufacture
Lead Partner: STATICE
Establish clinical-grade manufacturing processes.

Work Package 9: Dissemination and Exploitation
Lead Partner: C3BS
Protection, dissemination and exploitation of the technology developed during the project.

Work Package 10: Project Management
Lead Partner: EURAM
Management of the project and support liaison with the EC and ensure delivery of project results.