BALANCEProject reference: 304914
Funded under: FP7-HEALTH
Development of a bioartificial liver therapy in acute liver failure
Total cost:EUR 7 743 215,4
EU contribution:EUR 5 996 180
Call for proposal:FP7-HEALTH-2012-INNOVATION-2
Funding scheme:CP-FP - Small or medium-scale focused research project
"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."
EU contribution: EUR 1 665 612,6
Tel.: +31 20 56 62695
EU contribution: EUR 1 217 740
1105 AZ AMSTERDAM ZUIDOOST
Tel.: +31 20 6423533
EU contribution: EUR 1 726 376,4
Tel.: +31 43 3509910
Fax: +31 43 3619732
EU contribution: EUR 740 001
OLD COLLEGE, SOUTH BRIDGE
EH8 9YL EDINBURGH
Tel.: +44 131 650 9024
Fax: +44 131 650 9023
EU contribution: EUR 646 450
PARC D'ACTIVITE DE LA BRETECHE BATIMENT A4
35760 SAINT GREGOIRE
Tel.: +33 299 143614