Hep-Art Medical Devices B.V. is a spin off company of the Academic Medical Center of the University of Amsterdam (the Netherlands). The company has developed a robust bio-artificial liver system, the AMC-BAL. The AMC-BAL has been developed to support end stage liver failure (ESLF) patients like acute liver failure (ALF) and acute on chronic liver failure (ACLF) 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 I/IIa study with ALF patients.
To comply with the EU standards and thus replace the pig cells for human cells, we have 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, significantly delay of hepatic encephalopathy grade 4 and of deterioration of kidney function. We are currently , preparing a first clinical trial with the HepaRG-AMC-BAL in patients with ACLF (severe alcoholic hepatitis)..