Table 1.

BALs to be commercialized

Company	Device	Characteristics	Clinical experience & future plans
HepaLife	Hepa-Mate™ (previously HepatAssist)	Cryopreserved porcine cells, treatment 3-6 h for 1-5 d, charcoal column, and centrifugal plasmapheresis. Cell mass previously 60 g, in future trial 160 g	Phase II/III with HepatAssist in 171 ALF patients, only 9% improvement in OLT/NR as compared to controls. New trial in preparation
Vital therapies	ELAD®	Two-chambered hollow fiber cartridge with immortalized human C3A cell line. Treatment up to 10 d. Ultrafiltrate perfusion. 4 replaceable cartridges. Cell mass 4 g × 200 g	Controlled study with 25 ALF patients completed. 92% recovery OLT/NR. Controlled clinical trial in 49 AoCLD patients in China
Beijing and Nanjing Universities	TECA-BALSS/HBAL	Porcine cells (10-20 billion cells), outside compartment of hollow fiber devices	Phase I, 15 patients ALF and 3 patients AoCLD
Hep-Art	AMC-BAL	Perfused scaffold, oxygenation in situ, 10-15 billion freshly isolated SPF porcine hepatocytes	Phase I/IIa; 14 ALF patients. Safe, no PERV transmission

BAL: Biological artificial liver; ALF: Acute liver failure; OLT: Orthotopic liver transplant; AoCLD: Acute on chronic liver disease; PERV: Porcine endogenous retrovirus; NR: Native recovery; SPF: Specified pathogen-free; ELAD^®: Extracorporeal Liver Assist Device; BALSS: Bioartificial Liver Support Systems; HBAL: Hybrid Bioartificial Liver; AMC-BAL: Academic Medical Center University of Amsterdam-Bioartificial Liver.