Obiettivo 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. Campo scientifico engineering and technologymechanical engineeringmanufacturing engineeringengineering and technologyenvironmental biotechnologybioremediationbioreactorsnatural sciencesbiological sciencesecologyecosystemsmedical and health sciencesclinical medicinetransplantationmedical and health sciencesmedical biotechnologytissue engineeringbioartificial liver Programma(i) FP7-HEALTH - Specific Programme "Cooperation": Health Argomento(i) HEALTH.2012.1.4-2 - Medical technology for transplantation and bioartificial organs Invito a presentare proposte FP7-HEALTH-2012-INNOVATION-2 Vedi altri progetti per questo bando Meccanismo di finanziamento CP-FP - Small or medium-scale focused research project Coordinatore ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM Contributo UE € 1 665 612,60 Indirizzo MEIBERGDREEF 15 1105AZ Amsterdam Paesi Bassi Mostra sulla mappa Regione West-Nederland Noord-Holland Groot-Amsterdam Tipo di attività Higher or Secondary Education Establishments Contatto amministrativo Rebecca Massonet (Ms.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato Partecipanti (4) Classifica in ordine alfabetico Classifica per Contributo UE Espandi tutto Riduci tutto HEP-ART MEDICAL DEVICES BV Paesi Bassi Contributo UE € 1 217 740,00 Indirizzo MEIBERGDREEF 9 1105 AZ AMSTERDAM ZUIDOOST Mostra sulla mappa Regione West-Nederland Noord-Holland Groot-Amsterdam Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Jan Apers (Mr.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato LONZA NETHERLANDS BV Partecipazione conclusa Paesi Bassi Contributo UE € 1 726 376,40 Indirizzo OXFORDLAAN 70 6229 EV Maastricht Mostra sulla mappa Regione Zuid-Nederland Limburg (NL) Zuid-Limburg Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Alexander Vos (Mr.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato THE UNIVERSITY OF EDINBURGH Regno Unito Contributo UE € 740 001,00 Indirizzo OLD COLLEGE, SOUTH BRIDGE EH8 9YL Edinburgh Mostra sulla mappa Regione Scotland Eastern Scotland Edinburgh Tipo di attività Higher or Secondary Education Establishments Contatto amministrativo Angela Noble (Ms.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato BIOPREDIC INTERNATIONAL SARL Francia Contributo UE € 646 450,00 Indirizzo PARC D'ACTIVITE DE LA BRETECHE BATIMENT A4 35760 SAINT GREGOIRE Mostra sulla mappa Regione Bretagne Bretagne Ille-et-Vilaine Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Christophe Chesne (Dr.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato