Published online Jul 21, 2019. doi: 10.3748/wjg.v25.i27.3634
Peer-review started: March 20, 2019
First decision: March 27, 2019
Revised: May 3, 2019
Accepted: May 31, 2019
Article in press: June 1, 2019
Published online: July 21, 2019
Processing time: 122 Days and 9.5 Hours
Acute liver failure (ALF) has a high mortality varying from 80% to 85% with rapid progress in multi-organ system failure. Bioartificial liver (BAL) support systems have a potential effect to provide temporary support to bridge patients with acute liver failure to liver transplantation or spontaneous recovery. In the past decades, several BAL support systems have been conducted in clinical trials, but remained verified. More recently, concerns have been raised on the renovation of high-quality cell sources and configuration of BAL support systems to provide more benefits to ALF models in preclinical experiments.
A systematic review and meta-analysis of the existing literature on the use of BAL among humans and large animals with ALF could help bridge the gap between preclinical experiments and clinical trials regarding the effect of BAL for treating acute liver failure.
To investigate the characteristics of studies about BAL for ALF, and to evaluate their effects on mortality.
Eligible clinical trials and preclinical experiments on large animals were identified on Cochrane Library, PubMed, and EMbase up to March 6, 2019. Two reviewers independently extracted the necessary information, including the key BAL indicators, survival and indicating outcomes, and adverse events during treatment. Descriptive analysis was used to identify the characteristics of the included studies, and a meta-analysis by including only RCT studies was performed to combine the overall effect of BAL on mortality among humans and large animal, respectively.
Of 30 selected studies, 18 were clinical trials and 12 were preclinical experiments. The meta-analysis results suggested that BAL might reduce the mortality of ALF in large animals, probably due to the recent improvement of BAL, including the type, cell source, cell mass, and bioreactor, but seemed ineffective for humans. Liver and renal functions, hematologic and coagulative parameters, encephalopathy index, and neurological indicators seemed to improve after BAL, with neither meaningful adverse events nor porcine endogenous retrovirus infection.
BAL may reduce the mortality of ALF by bridging the gap between preclinical experiments and clinical trials. Clinical trials using improved BAL must be designed scientifically and conducted in the future to provide evidence for transformation.
Our study could provide some suggestions for future clinical trials, preclinical experiments, and transformations. First, alternative cells or methods for acquiring high-quality liver cells in vitro must be identified to achieve clinical-scale goals. Second, the effects of the subgroups, patients with PNF or FHF, and patients with different etiologies should be determined and examined in clinical trials in the future. Finally, the advanced BAL, which proved to have a significant benefit on the survival outcome of the large-animal ALF model, should undergo clinical transformation as much as possible.