Bioartificial liver support systems for acute liver failure: A systematic review and meta-analysis of the clinical and preclinical literature

Table 1 Characteristics of bioartificial liver support system and subjects of clinical trials

ID	Publication year	Type of trial	BAL system				Subject
			Type	Hybrid	Cell	Mass	Sample No.	Subtype	Age	Sex	Disease etiology
1	1994	Non-controlled trial	HepatAssist	Yes	Porcine hepatocytes	6 × 109	7	FHF 6 PNF 1	10-58	4M:3F	PNF 1 ; Virus 1; AO 2; Indeterminate 3
2	1997	Non-controlled trial	HepatAssist	Yes	Porcine hepatocytes	5 × 109	21	FHF 18	36.1 ± 3.4	7M:11F	Virus 4; Indeterminate 8; AO 4; Ischemic 2
								PNF 3	48.3 ± 11.2	1M:2F	Virus 1; Indeterminate 1; Autoimmune 1
3	2010	Non-controlled trial	HepatAssist	Yes	Porcine hepatocytes	5 × 109	18	FHF 15	10-56	10M;5F	Indeterminate 7; Virus 3; AO 4; Ischemic 1
								PNF 3	26-58	1M:2F	Indeterminate 1; Virus 1; Autoimmune 1;
4	2002	Non-controlled trial	HepatAssist	Yes	Porcine hepatocytes	5 × 109	10	FHF 10	31	4M:6F	Indeterminate 6; Virus 2; Wilson 1; Pyrazinamide 1
5	1994	Non-controlled trial	ELAD	No	C3A cells	200 g	11	FHF 10 PNF 1	38.5 ± 18.1	5M:6F	Idiopathic 1; Virus 3; AO 2; INH 1; FIAU 3; Anhepatic 1
6	2002	Non-controlled trial	ELAD	No	C3A cells	300-400g	5	FHF 5	22.2 ± 9.4	2M:3F	asparaginase toxicity 1; Indeterminate 3; Autoimmune 1
7	2002	Phase I trial	AMC-BAL	No	Porcine hepatocytes	11.9 × 109	7	FHF 7	34.3 ± 15.2	2M:5F	Virus 4; AFLP 1; Indeterminate 2
8	2003	Case report	AMC-BAL	No	Porcine hepatocytes	10 × 109	1	FHF	35	F	Virus 1
9	1996	Non-controlled trial	NR	No	Porcine hepatocytes	5 × 109	12	FHF 11 PNF 1	37.2 ± 15.5	6M:6F	Indeterminate 4; AO 2; Virus 3; Ischemic Failure 1; Autoimmune 1; PNF 1
10	2003	Phase I trial	MELS	Yes	Porcine hepatocytes; non-parenchymal cells	(1.8-4.4) × 1010	8	FHF 8	34.3	1M:7F	Rug-related 2; Virus 3; Indeterminate 3
11	2003	Case report	MELS	Yes	Human hepatocytes	470 g	1	PNF	26	F	Intoxication with amanita phalloides
12	2002	Case report	BLSS	No	Porcine hepatocytes	70-100 g	1	FHF	41	F	Indeterminate 1
13	2002	Non-controlled trial	RFB-BAL	No	Porcine hepatocytes	200-230 g	7	FHF 4 PNF 3	37.4 ± 18.4	5M:2F	Virus 3; PNF 3; Liver trauma 1
14	2003	Non-controlled trial	HBAL	Yes	Porcine hepatocytes	1.0 × 109	12	FHF 12	41.8 ± 13.0	9M:3F	Virus 12
15	1999	Non-controlled trial	HepatAssis	Yes	Porcine hepatocytes	5 × 109	8	FHF 8	33.4 ± 11.0	1M:7F	AO 8
161	2018	Phase 1/2a Trial	LifeLiver BAL	NR	Porcine hepatocytes spheroids	NR	8	FHF 8	NR	NR	NR
17	1996	Pilot-Controlled Trial	ELAD	No	C3A cells	400 g	Group-1 17	FHF 17	30	6M:3F vs 3M:5F2	AO 5, Virus 3, ATB 5 vs AO 6, Virus 12; ATB 1
							Group-2 7	FHF 7		0M:3F vs 3M:1F2	AO 3 vs AO 3, Virus 12
18	2004	RCT	HepatAssist	Yes	Porcine hepatocytes	7 × 109	171	FHF 147 PNF 24	37	26M:60F vs 25M:60F2	Known causes 83, Indeterminate 64

¹Data from abstract;

²Intervention vs control; NA: Not applicable; NR: Not reported; Sex: Male (M) and Female (F); ELAD: Extracorporeal liver assist device; BAL: Bioartificial liver; AMC-BAL: Academic medical center bioartificial liver ; MELS: Modular extracorporeal liver support; BLSS: Novel bioartificial liver support system; RFB-BAL: Radial-flow bioreactor bioartificial liver; HBAL: Hybrid bioartificial liver; FBBAL: Fluidized bed bioartificial liver; HBALSS: Hybrid bioartificial liver support system; PNF: Primary nonfunction; FHF: Fulminant hepatic failure; AO: Acetaminophen; INH: Isoniazid; FIAU: Fialuridine; AFLP: Acute fatty liver of pregnancy; ATB: Anti-tuberculous hepatotoxicity; PERV: Porcine endogenous retrovirus; RCT: Randomized controlled trial.