Literature DB >> 25817557

Pivotal preclinical trial of the spheroid reservoir bioartificial liver.

Jaime M Glorioso1, Shennen A Mao1, Brian Rodysill1, Taufic Mounajjed2, Walter K Kremers3, Faysal Elgilani4, Raymond D Hickey5, Hakon Haugaa6, Christopher F Rose7, Bruce Amiot8, Scott L Nyberg9.   

Abstract

BACKGROUND & AIMS: The neuroprotective effect of the spheroid reservoir bioartificial liver (SRBAL) was evaluated in a porcine model of drug-overdose acute liver failure (ALF).
METHODS: Healthy pigs were randomized into three groups (standard therapy (ST) alone, ST+No-cell device, ST+SRBAL device) before placement of an implantable intracranial pressure (ICP) monitor and a tunneled central venous catheter. One week later, pigs received bolus infusion of the hepatotoxin D-galactosamine and were followed for up to 90h.
RESULTS: At 48h, all animals had developed encephalopathy and biochemical changes confirming ALF; extracorporeal treatment was initiated and pigs were observed up to 90h after drug infusion. Pigs treated with the SRBAL, loaded with porcine hepatocyte spheroids, had improved survival (83%, n=6) compared to ST alone (0%, n=6, p=0.003) and No-cell device therapy (17%, n=6, p=0.02). Ammonia detoxification, peak levels of serum ammonia and peak ICP, and pig survival were influenced by hepatocyte cell dose, membrane pore size and duration of SRBAL treatment. Hepatocyte spheroids remained highly functional with no decline in mean oxygen consumption from initiation to completion of treatment.
CONCLUSIONS: The SRBAL improved survival in an allogeneic model of drug-overdose ALF. Survival correlated with ammonia detoxification and ICP lowering indicating that hepatocyte spheroids prevented the cerebral manifestations of ALF (brain swelling, herniation, death). Further investigation of SRBAL therapy in a clinical setting is warranted.
Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Entities:  

Keywords:  Bioartificial liver; D-galactosamine; Hepatocyte; Liver failure; Spheroid

Mesh:

Year:  2015        PMID: 25817557      PMCID: PMC4508211          DOI: 10.1016/j.jhep.2015.03.021

Source DB:  PubMed          Journal:  J Hepatol        ISSN: 0168-8278            Impact factor:   25.083


  34 in total

1.  Membrane barrier of a porcine hepatocyte bioartificial liver.

Authors:  Scott L Nyberg; Toshikazu Yagi; Takakazu Matsushita; Joseph Hardin; Joseph P Grande; Lawrence E Gibson; Jeffrey L Platt
Journal:  Liver Transpl       Date:  2003-03       Impact factor: 5.799

Review 2.  Artificial and bioartificial support systems for acute and acute-on-chronic liver failure: a systematic review.

Authors:  Lise L Kjaergard; Jianping Liu; Bodil Als-Nielsen; Christian Gluud
Journal:  JAMA       Date:  2003-01-08       Impact factor: 56.272

3.  Early experiences with a porcine hepatocyte-based bioartificial liver in acute hepatic failure patients.

Authors:  E Morsiani; P Pazzi; A C Puviani; M Brogli; L Valieri; P Gorini; P Scoletta; E Marangoni; R Ragazzi; G Azzena; E Frazzoli; D Di Luca; E Cassai; G Lombardi; A Cavallari; S Faenza; A Pasetto; M Girardis; E Jovine; A D Pinna
Journal:  Int J Artif Organs       Date:  2002-03       Impact factor: 1.595

4.  Primary human liver cells as source for modular extracorporeal liver support--a preliminary report.

Authors:  I M Sauer; K Zeilinger; N Obermayer; G Pless; A Grünwald; A Pascher; T Mieder; S Roth; M Goetz; D Kardassis; A Mas; P Neuhaus; J C Gerlach
Journal:  Int J Artif Organs       Date:  2002-10       Impact factor: 1.595

5.  Selective plasma filtration for treatment of fulminant hepatic failure induced by D-galactosamine in a pig model.

Authors:  D W Y Ho; S T Fan; J To; Y H Woo; Z Zhang; C Lau; J Wong
Journal:  Gut       Date:  2002-06       Impact factor: 23.059

6.  Prospective, randomized, multicenter, controlled trial of a bioartificial liver in treating acute liver failure.

Authors:  Achilles A Demetriou; Robert S Brown; Ronald W Busuttil; Jeffrey Fair; Brendan M McGuire; Philip Rosenthal; Jan Schulte Am Esch; Jan Lerut; Scott L Nyberg; Mauro Salizzoni; Elizabeth A Fagan; Bernard de Hemptinne; Christoph E Broelsch; Maurizio Muraca; Joan Manuel Salmeron; John M Rabkin; Herold J Metselaar; Daniel Pratt; Manuel De La Mata; Lawrence P McChesney; Gregory T Everson; Philip T Lavin; Anthony C Stevens; Zorina Pitkin; Barry A Solomon
Journal:  Ann Surg       Date:  2004-05       Impact factor: 12.969

7.  A simple gravimetric technique for measurement of cerebral edema.

Authors:  A Marmarou; W Poll; K Shulman; H Bhagavan
Journal:  J Neurosurg       Date:  1978-10       Impact factor: 5.115

8.  Human hepatocellular carcinoma cell lines secrete the major plasma proteins and hepatitis B surface antigen.

Authors:  B B Knowles; C C Howe; D P Aden
Journal:  Science       Date:  1980-07-25       Impact factor: 47.728

9.  Clinical extracorporeal hybrid liver support--phase I study with primary porcine liver cells.

Authors:  I M Sauer; D Kardassis; K Zeillinger; A Pascher; A Gruenwald; G Pless; M Irgang; M Kraemer; G Puhl; J Frank; A R Müller; T Steinmüller; J Denner; P Neuhaus; J C Gerlach
Journal:  Xenotransplantation       Date:  2003-09       Impact factor: 3.907

10.  Membrane pore size impacts performance of a xenogeneic bioartificial liver.

Authors:  Takakazu Matsushita; Bruce Amiot; Joseph Hardin; Jeffrey L Platt; Scott L Nyberg
Journal:  Transplantation       Date:  2003-11-15       Impact factor: 4.939

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  21 in total

Review 1.  Concise Review: Liver Regenerative Medicine: From Hepatocyte Transplantation to Bioartificial Livers and Bioengineered Grafts.

Authors:  Clara T Nicolas; Raymond D Hickey; Harvey S Chen; Shennen A Mao; Manuela Lopera Higuita; Yujia Wang; Scott L Nyberg
Journal:  Stem Cells       Date:  2016-10-02       Impact factor: 6.277

2.  Randomized Trial of Spheroid Reservoir Bioartificial Liver in Porcine Model of Posthepatectomy Liver Failure.

Authors:  Harvey S Chen; Dong Jin Joo; Mohammed Shaheen; Yi Li; Yujia Wang; Jian Yang; Clara T Nicolas; Kelly Predmore; Bruce Amiot; Gregory Michalak; Taofic Mounajjed; Jeff Fidler; Walter K Kremers; Scott L Nyberg
Journal:  Hepatology       Date:  2018-12-27       Impact factor: 17.425

Review 3.  Proceedings from the 2018 Canadian Association for the Study of the Liver Single Topic Conference-Decompensated cirrhosis: from clinic to transplant.

Authors:  Victor Dong; Maxime Gosselin; Nishita Jagarlamudi; Beverley Kok; Mark G Swain; Jasmohan S Bajaj; Juan G Abraldes; Vladimir Marquez; R Todd Stravitz; Aldo J Montano-Loza; Manuela Merli; Phil Wong; Amanda Brisebois; Puneeta Tandon; Julia Wendon; Scott L Nyberg; François M Carrier; Michael R Lucey; Florence Wong; Jordan J Feld; Constantine J Karvellas; Christopher F Rose; Julien Bissonnette
Journal:  Can Liver J       Date:  2019-12-10

Review 4.  Cell therapy in chronic liver disease.

Authors:  Clara T Nicolas; Yujia Wang; Scott L Nyberg
Journal:  Curr Opin Gastroenterol       Date:  2016-05       Impact factor: 3.287

5.  Laparoscopic left hemihepatectomy combined with right lateral hepatic lobectomy in pigs: surgical approach and comparative study of the inflammatory response versus open surgery.

Authors:  Hua Zhang; Jin-Jin Tong; Zhao-Nan Zhang; Hong-Bin Wang; Yong-Hong Zhang
Journal:  Vet Res Forum       Date:  2021-03-15       Impact factor: 1.054

6.  Establishment of a Novel Simplified Surgical Model of Acute Liver Failure in the Cynomolgus Monkey.

Authors:  Lei Cai; Jun Weng; Lei Feng; Guolin He; Jiasheng Qin; Zhi Zhang; Yang Li; Qing Peng; Zesheng Jiang; Mingxin Pan; Yi Gao
Journal:  Biomed Res Int       Date:  2016-12-21       Impact factor: 3.411

7.  Selecting Cells for Bioartificial Liver Devices and the Importance of a 3D Culture Environment: A Functional Comparison between the HepaRG and C3A Cell Lines.

Authors:  Martien van Wenum; Aziza A A Adam; Theodorus B M Hakvoort; Erik J Hendriks; Valery Shevchenko; Thomas M van Gulik; Robert A F M Chamuleau; Ruurdtje Hoekstra
Journal:  Int J Biol Sci       Date:  2016-06-24       Impact factor: 6.580

8.  Fiber scaffold bioartificial liver therapy relieves acute liver failure and extrahepatic organ injury in pigs.

Authors:  Jun Weng; Xu Han; Fanhong Zeng; Yue Zhang; Lei Feng; Lei Cai; Kangyan Liang; Shusong Liu; Shao Li; Gongbo Fu; Min Zeng; Yi Gao
Journal:  Theranostics       Date:  2021-06-11       Impact factor: 11.556

Review 9.  New Phase of Growth for Xenogeneic-Based Bioartificial Organs.

Authors:  Zorina Pitkin
Journal:  Int J Mol Sci       Date:  2016-09-21       Impact factor: 5.923

10.  Improved survival of porcine acute liver failure by a bioartificial liver device implanted with induced human functional hepatocytes.

Authors:  Xiao-Lei Shi; Yimeng Gao; Yupeng Yan; Hucheng Ma; Lulu Sun; Pengyu Huang; Xuan Ni; Ludi Zhang; Xin Zhao; Haozhen Ren; Dan Hu; Yan Zhou; Feng Tian; Yuan Ji; Xin Cheng; Guoyu Pan; Yi-Tao Ding; Lijian Hui
Journal:  Cell Res       Date:  2016-01-15       Impact factor: 25.617

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