Skip to main content

Development of a bioartificial liver therapy in acute liver failure

Objective

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.

Field of science

  • /medical and health sciences/medical biotechnology/tissue engineering/bioartificial liver
  • /medical and health sciences/clinical medicine/transplantation

Call for proposal

FP7-HEALTH-2012-INNOVATION-2
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Address
Meibergdreef 15
1105AZ Amsterdam
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 665 612,60
Administrative Contact
Rebecca Massonet (Ms.)

Participants (4)

HEP-ART MEDICAL DEVICES BV
Netherlands
EU contribution
€ 1 217 740
Address
Meibergdreef 9
1105 AZ Amsterdam Zuidoost
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jan Apers (Mr.)
LONZA NETHERLANDS BV

Participation ended

Netherlands
EU contribution
€ 1 726 376,40
Address
Oxfordlaan 70
6229 EV Maastricht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Alexander Vos (Mr.)
THE UNIVERSITY OF EDINBURGH
United Kingdom
EU contribution
€ 740 001
Address
Old College, South Bridge
EH8 9YL Edinburgh
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Angela Noble (Ms.)
BIOPREDIC INTERNATIONAL SARL
France
EU contribution
€ 646 450
Address
Parc D'activite De La Breteche Batiment A4
35760 Saint Gregoire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Christophe Chesne (Dr.)