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In-silico Development- and Clinical-Trial-Platform for Testing in-situ Tissue Engineered Heart Valves

Objective

SimInSitu is aiming to develop a sophisticated in-silico method to predict the short- and long-term behavior of in-situ tissue engineered heart valves by combing advanced tissue remodeling algorithms with a personalized virtual heart modelling approach. The method will be specifically developed to predict the complex transformation process of biodegradable heart valves from the initially synthetic scaffold into a fully remodeled & functional valve. This transformation process, named ETR for Endogenous Tissue Restoration, is the core technology for a new generation of very promising biodegradable vascular device currently developed by Xeltis. ETR makes the use of animal derived tissue, which is used in the majority of commercially available bioprosthetic heart valves, obsolete and avoids thereby durability related issues and potentially minimized the need for reoperations. Though, significant progress was made during the past years in developing ERT based devices, it remains very challenging, costly, time-consuming, and rich with obstacles. New knowledge can only be generated through a tedious trial & error process (requiring preclinical and clinical studies), since the restorative process cannot be replicated in an in-vitro environment. Advanced Computer Modelling & Simulation technologies have the potential to overcome this limitation by allowing to test new designs, modified scaffold compositions, or other applications in a virtual patient-specific environment – in-silico. SimInSitu will not only develop such a computer model, but will also verify and validate it thoroughly by making use of the extensive in-vitro and in-vivo data available and where necessary will generate new data to support the credibility of this in-silico method. The availability of this computer model could contribute significantly to an acceleration of especially the ETR-device development and accelerate their translation into the clinic and market.

Call for proposal

H2020-SC1-DTH-2020-1
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Funding Scheme

RIA - Research and Innovation action

Coordinator

4REALSIM SERVICES BV
Address
Benschopperstraat 34
3401 DH Ijsselstein
Netherlands
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 1 226 562,50

Participants (8)

UNIVERSITA DEGLI STUDI DI PALERMO
Italy
EU contribution
€ 652 720
Address
Piazza Marina 61
90133 Palermo
Activity type
Higher or Secondary Education Establishments
ASSOCIATION POUR LA RECHERCHE ET LE DEVELOPPEMENT DES METHODES ET PROCESSUS INDUSTRIELS
France
EU contribution
€ 482 625
Address
Boulevard Saint Michel 60
75272 Paris
Activity type
Research Organisations
LEARTIKER, SCOOP
Spain
EU contribution
€ 181 000
Address
Av/ Xemein, 12
48270 Markina-xemein
Activity type
Research Organisations
XELTIS BV
Netherlands
EU contribution
€ 640 000
Address
De Lismortel R2 06 Cat Build 31
5612 AR Eindhoven
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CAPVIDIA
Belgium
EU contribution
€ 920 625
Address
Technologielaan 3
3001 Heverlee
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TECHNISCHE UNIVERSITAET GRAZ
Austria
EU contribution
€ 293 972,50
Address
Rechbauerstrasse 12
8010 Graz
Activity type
Higher or Secondary Education Establishments
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 825 687,50
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE SRL - ISMETT SRL
Italy
EU contribution
€ 187 500
Address
Discesa Dei Giudici 4
90133 Palermo
Activity type
Other