Cel 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. Dziedzina nauki engineering and technologymechanical engineeringmanufacturing engineeringengineering and technologyenvironmental biotechnologybioremediationbioreactorsnatural sciencesbiological sciencesecologyecosystemsmedical and health sciencesclinical medicinetransplantationmedical and health sciencesmedical biotechnologytissue engineeringbioartificial liver Program(-y) FP7-HEALTH - Specific Programme "Cooperation": Health Temat(-y) HEALTH.2012.1.4-2 - Medical technology for transplantation and bioartificial organs Zaproszenie do składania wniosków FP7-HEALTH-2012-INNOVATION-2 Zobacz inne projekty w ramach tego zaproszenia System finansowania CP-FP - Small or medium-scale focused research project Koordynator ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM Wkład UE € 1 665 612,60 Adres MEIBERGDREEF 15 1105AZ Amsterdam Niderlandy Zobacz na mapie Region West-Nederland Noord-Holland Groot-Amsterdam Rodzaj działalności Higher or Secondary Education Establishments Kontakt administracyjny Rebecca Massonet (Ms.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych Uczestnicy (4) Sortuj alfabetycznie Sortuj według wkładu UE Rozwiń wszystko Zwiń wszystko HEP-ART MEDICAL DEVICES BV Niderlandy Wkład UE € 1 217 740,00 Adres MEIBERGDREEF 9 1105 AZ AMSTERDAM ZUIDOOST Zobacz na mapie Region West-Nederland Noord-Holland Groot-Amsterdam Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Kontakt administracyjny Jan Apers (Mr.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych LONZA NETHERLANDS BV Zakończenie uczestnictwa Niderlandy Wkład UE € 1 726 376,40 Adres OXFORDLAAN 70 6229 EV Maastricht Zobacz na mapie Region Zuid-Nederland Limburg (NL) Zuid-Limburg Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Kontakt administracyjny Alexander Vos (Mr.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych THE UNIVERSITY OF EDINBURGH Zjednoczone Królestwo Wkład UE € 740 001,00 Adres OLD COLLEGE, SOUTH BRIDGE EH8 9YL Edinburgh Zobacz na mapie Region Scotland Eastern Scotland Edinburgh Rodzaj działalności Higher or Secondary Education Establishments Kontakt administracyjny Angela Noble (Ms.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych BIOPREDIC INTERNATIONAL SARL Francja Wkład UE € 646 450,00 Adres PARC D'ACTIVITE DE LA BRETECHE BATIMENT A4 35760 SAINT GREGOIRE Zobacz na mapie Region Bretagne Bretagne Ille-et-Vilaine Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Kontakt administracyjny Christophe Chesne (Dr.) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Koszt całkowity Brak danych