Hep-Art Medical Devices B.V. is a spin off company of the Academic Medical Center in Amsterdam. The company has developed a robust bio-artificial liver system, the AMC-BAL. The AMC-BAL has been developed to support acute liver failure (ALF) patients to liver recovery or to the moment of donor-liver availability. The AMC-BAL is an extracorporeal supportive device that treats the plasma of the patients and temporarily replaces liver functions. The core of the system is a bioreactor that is loaded with embedded liver cells (hepatocytes). When based on porcine liver cells, the system appeared safe during a first clinical phase 1 study with ALF patients.
To comply with the EU standards and thus replace the pig cells for human cells, we have developed the human liver cell line cBAL 111 and generated a protocol to mature the human HepaRG liver cell line in the AMC-BAL. The power of the current HepaRG-based AMC-BAL system is advocated by a study in rats with ALF showing substantial increased survival time.
We are currently, as one of the 5 participants in a large EU consortium, named BALANCE, preparing the first clinical trial with the AMC-BAL, using HepaRG liver cells, in patients with ALF.