Table 1.

Bioartificial liver devices used in clinical trials

Bioreactor device	Ref.	Cells	Mass (g)1	Bioreactor design	Scaffold	Fluid	Separation	Treatment time (h)	Phase	Indication (n)	Effect
HepatAssist	Demetriou et al[9]	Cryopreserved porcine hepatocytes	50-70	Hollow fiber	Microcarrier + external inoculation	Plasma	3000 kDa cut-off	6	III	ALF (147), PNF (24)	HepatAssist survival of 71.0% vs control survival of 62.0% P = 0.28, (NS)
Vitagen ELAD	Reich et al[10]	HepG2/C3A	200-400	Hollow fiber	External inoculation	Plasma	70 kDa cut-off	Up to 168	III	AILD (96)	ELAD survival of 80.4% vs control survival of 65.2% P = 0.068, (NS)
LSS	Mundt et al[7]	Primary porcine hepatocytes	up to 500	Hollow fiber	External inoculation	Plasma	300 kDa cut-off	7-46	I/II	ALF (8)	Bridged to OLT 8
MELS	Sauer et al[8]	Primary human hepatocytes	up to 600	Hollow fiber	External inoculation	Plasma	400 kDa cut-off	7-74	I	ALF (2), PNF (2), AOC(4)	Bridged to OLT 6, Survival without OLT 1, Died without OLT 1
Excorp Medical BLSS	Mazariegos et al[6]	Primary porcine hepatocytes	70-120	Hollow fiber	Collagen + external inoculation	Whole blood	100 kDa cut-off	12	I	ALF (2), AOC (2)	Bridged to OLT 1, Died without OLT 3
AMC-BAL	van de Kerkhove et al[13,14]	Primary porcine hepatocytes	100	Nonwoven	Spiral membrane + polyester matrix	Plasma	None	24	I	ALF (12)	Bridged to OLT 11, Survival without OLT 1

¹100 million cells/gram of liver. AILD: Alcohol-Induced Liver Decompensation; AOC: Acute-on-chronic liver failure; ALF: Acute liver failure; PNF: Primary graft nonfunction; OLT: Orthotopic liver transplantation.