Clinical translation of bioartificial liver support systems with human pluripotent stem cell-derived hepatic cells

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.