Guidelines For Clinical Practice
Copyright ©2009 Baishideng.
World J Gastrointest Surg. Nov 30, 2009; 1(1): 21-25
Published online Nov 30, 2009. doi: 10.4240/wjgs.v1.i1.21
Table 1 BALs to be commercialized
CompanyDeviceCharacteristicsClinical experience & future plans
HepaLifeHepa-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 gPhase II/III with HepatAssist in 171 ALF patients, only 9% improvement in OLT/NR as compared to controls. New trial in preparation
Vital therapiesELAD®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 gControlled study with 25 ALF patients completed. 92% recovery OLT/NR. Controlled clinical trial in 49 AoCLD patients in China
Beijing and Nanjing UniversitiesTECA-BALSS/HBALPorcine cells (10-20 billion cells), outside compartment of hollow fiber devicesPhase I, 15 patients ALF and 3 patients AoCLD
Hep-ArtAMC-BALPerfused scaffold, oxygenation in situ, 10-15 billion freshly isolated SPF porcine hepatocytesPhase I/IIa; 14 ALF patients. Safe, no PERV transmission