Table 1: Comparison of liver-assist devices made with primary hepatocytes versus an immortalized human liver cell line (C3A) | ||
Aspects of liver-assist devices | Primary hepatocytes | Cell line |
Ease of obtaining a large mass of cells | Difficult: automated system for cell isolation not available | Easy: clonal expansion of existing cell line |
Current count per cartridge | 6 × 109 (estimated 6-12 g) | 2 × 1011 (estimated 200 g) |
Cell survival during treatment | Limited: cells vacuolated after 7 h | Indefinite: viability up to 7 d |
Immunogenicity of infused proteins | Unknown, especially with repeated use | No problem after several days of treatment (human proteins) |
Risk of infectious agents | Unknown: screening of each sample or gnotobiotic animal may be required | Controlled culture conditions: master cell bank screened for human pathogens |
Risk of tumour | Negligible | Unknown; probably low (requires follow-up) |
Effectiveness in animal studies | Improved blood pressure and levels of blood chemicals after 6 h | Recovery from massive liver necrosis after 48 h |
Goal of treatment | Short-term treatment intended as a bridge to liver transplantation | Metabolic support until liver regenerates; bridge to liver transplantation is secondary goal |
Effectiveness in patients | Suggestive evidence; effectiveness must be proven in randomized trial | Suggestive evidence; effectiveness must be proven in randomized trial |
Cost | Labour intensive and therefore expensive | Expected to be less than or equal to US$20 000 per patient |