Objectif In BALANCE, the companies Hep-Art, Pharmacell and BioPredic join forces with academic partners Amsterdam Medical Centre and University of Edinburgh to offer Acute Liver Failure (ALF) patients a bioartificial liver-support system for bridging the waiting period for liver transplantation or recovery of the diseased liver.ALF is a highly lethal disorder and liver transplantation is the only life-saving therapy. However, limited availability of donor livers severely reduces its impact. A bioartificial liver (BAL) may support ALF patients by temporary and extracorporeal treatment of their plasma through a bioreactor with functional human liver cells.The central objective of BALANCE is to develop a HepaRG-BAL that executes the three key liver functions for a clinically relevant period in ALF and to reach proof of safety and feasibility. What makes the HepaRG-BAL extremely potent is the unique combination of an ideal liver cell ecosystem and the introduction of the HepaRG cell line which is the only human cell line in the world that approaches human liver in its functionality.A two-staged approach will be adopted. Stage I is designed for in-vitro optimisation of the BAL and the human cell line and stage II comprises of the ex-vivo activities in which the optimized and upscaled BAL is tested and validated in pigs (controlled study). In addition approvement of a Phase I/IIa in humans will be prepared. .BALANCE will give birth to four main results: an optimised and validated BAL, a large scale manufacturing process, proof of concept in a large animal model of ALF and basic information for regulatory approval for future clinical application. Hep-Art will further pursue clinical development of the BAL towards EMA registration and marketing together with a large industrial partner. BioPredic will further exploit the HepaRG cells. Last but not least, BALANCE will strengthen the European competitive advantage in the field of bioartificial organs. Champ scientifique engineering and technologymechanical engineeringmanufacturing engineeringengineering and technologyenvironmental biotechnologybioremediationbioreactorsnatural sciencesbiological sciencesecologyecosystemsmedical and health sciencesclinical medicinetransplantationmedical and health sciencesmedical biotechnologytissue engineeringbioartificial liver Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Thème(s) HEALTH.2012.1.4-2 - Medical technology for transplantation and bioartificial organs Appel à propositions FP7-HEALTH-2012-INNOVATION-2 Voir d’autres projets de cet appel Régime de financement CP-FP - Small or medium-scale focused research project Coordinateur ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM Contribution de l’UE € 1 665 612,60 Adresse MEIBERGDREEF 15 1105AZ Amsterdam Pays-Bas Voir sur la carte Région West-Nederland Noord-Holland Groot-Amsterdam Type d’activité Higher or Secondary Education Establishments Contact administratif Rebecca Massonet (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée Participants (4) Trier par ordre alphabétique Trier par contribution de l’UE Tout développer Tout réduire HEP-ART MEDICAL DEVICES BV Pays-Bas Contribution de l’UE € 1 217 740,00 Adresse MEIBERGDREEF 9 1105 AZ AMSTERDAM ZUIDOOST Voir sur la carte Région West-Nederland Noord-Holland Groot-Amsterdam Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Jan Apers (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée LONZA NETHERLANDS BV Participation terminée Pays-Bas Contribution de l’UE € 1 726 376,40 Adresse OXFORDLAAN 70 6229 EV Maastricht Voir sur la carte Région Zuid-Nederland Limburg (NL) Zuid-Limburg Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Alexander Vos (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée THE UNIVERSITY OF EDINBURGH Royaume-Uni Contribution de l’UE € 740 001,00 Adresse OLD COLLEGE, SOUTH BRIDGE EH8 9YL Edinburgh Voir sur la carte Région Scotland Eastern Scotland Edinburgh Type d’activité Higher or Secondary Education Establishments Contact administratif Angela Noble (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée BIOPREDIC INTERNATIONAL SARL France Contribution de l’UE € 646 450,00 Adresse PARC D'ACTIVITE DE LA BRETECHE BATIMENT A4 35760 SAINT GREGOIRE Voir sur la carte Région Bretagne Bretagne Ille-et-Vilaine Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Christophe Chesne (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée