Project Details
Description
Acronyme: BALANCE
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 GMP certified 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) and humans with ALF (phase I/IIa clinical study).
BALANCE will give birth to three main results: an optimised and validated BAL, a GMP manufacturing process and a GMP grade and stable human liver cell line. Hep-Art will further pursue clinical development of the BAL towards EMA registration and marketing together with a large industrial partner. Pharmacell will exploit the GMP manufacturing process for production of the trial and commercial material. BioPredic will further exploit the GMP-graded HepaRG cells. Last but not least, BALANCE will strengthen the European competitive advantage in the field of bioartificial organs.
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 GMP certified 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) and humans with ALF (phase I/IIa clinical study).
BALANCE will give birth to three main results: an optimised and validated BAL, a GMP manufacturing process and a GMP grade and stable human liver cell line. Hep-Art will further pursue clinical development of the BAL towards EMA registration and marketing together with a large industrial partner. Pharmacell will exploit the GMP manufacturing process for production of the trial and commercial material. BioPredic will further exploit the GMP-graded HepaRG cells. Last but not least, BALANCE will strengthen the European competitive advantage in the field of bioartificial organs.
| Status | Active |
|---|---|
| Effective start/end date | 1/05/2013 → … |