Information de reference pour ce titreAccession Number: | 00000658-199705000-00005.
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Author: | Watanabe, Frederick D. M.D. *; Mullon, Claudy J-P Ph.D. +; Hewitt, Winston R. M.D. *; Arkadopoulos, Nicholas M.D. *; Kahaku, Elaine R.N. *; Eguchi, Susumu M.D. *; Khalili, Theodore M.D. *; Arnaout, Walid M.D. *; Shackleton, Christopher R. M.D. *; Rozga, Jacek M.D., Ph.D. *; Solomon, Barry Ph.D. +; Demetriou, Achilles A. M.D., Ph.D. *
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Institution: | From the Liver Support Unit,* Department of Surgery, Cedars-Sinai Medical Center, UCLA School of Medicine, Los Angeles, Califomia; and Circe Biomedical,+ Lexington, Massachusetts
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Title: | Clinical Experience With a Bioartificial Liver in the Treatment of Severe Liver Failure: A Phase I Clinical Trial.[Article]
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Source: | Annals of Surgery. 225(5):484-494, May 1997.
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Abstract: | Objective: The purpose of this study was to develop a bioartificial liver (BAL) to treat patients with severe liver failure until they can be either transplanted or recover spontaneously.
Summary Background Data: Severe acute liver failure is associated with high mortality. Liver transplantation has emerged as an effective therapy for patients who did not respond to standard management. However, because of the donor organ shortage and urgent need for transplantation, many patients die before they can be transplanted and others do not survive after transplantation, primarily because of intracranial hypertension.
Methods: Three groups of patients with severe acute liver failure were treated with the BAL. In group 1 (n = 18) were patients with fulminant hepatic failure (FHF), in group 2 (n = 3) were patients with primary nonfunction (PNF) of a transplanted liver, and in group 3 (n = 10) were patients with acute exacerbation of chronic liver disease. Patients in groups 1 and 2 were candidates for transplantation at the time they entered the study, whereas patients in group 3 were not.
Results: In group 1, 16 patients were "bridged" successfully to transplantation, 1 patient was bridged to recovery without a transplant, and 1 patient died because of concomitant severe pancreatitis. In group 2, all patients were bridged successfully to retransplantation. In group 3, two patients were supported to recovery and successful transplants at later dates; the other eight patients, although supported temporarily with the BAL, later died because they were not candidates for transplantation.
Conclusions: The authors' clinical experience with the BAL has yielded encouraging results. A randomized, controlled, prospective trial (phase II-III) is being initiated to determine the efficacy of the system.
(C) Lippincott-Raven Publishers.
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References: | 1. Lee WM. Acute liver failure. N Engl J Med 1993; 329:1862-1868.
2. Demetriou AA. Support of the Acutely Failing Liver. Medical Intelligence Unit. Austin: RG Landes; 1994.
3. Bihari D, Hughes RD, Gimson AES, et al. Effect of serial resin hemoperfusion in fulminant hepatic failure. Int J Artif Organs 1983; 6:299-302.
4. Gimson AES, Mellon PJ, Braude S, et al. Earlier charcoal hemoperfusion in fulminant hepatic failure. Lancet 1982; ii:68-83.
5. Silk DBA, Trewby PN, Chase RA, et al. Treatment of fulminant hepatic failure by polyacrylonitrile membrane hemodialysis. Lancet 1977; ii:1-3.
6. Redeker AG, Yamahiro HS. Controlled trial of exchange transfusion therapy in fulminant hepatitis. Lancet 1973; ii:3-6.
7. Cooper GN, Karlson KE, Clowes GHA, et al. Total body washout and exchange. A valuable tool in acute hepatic coma and Reye's syndrome. Am J Surg 1977; 133:522-530.
8. Fox IJ, Langnas AN, Ozaki CF, et al. Successful application of extracorporeal liver perfusion for the treatment of fulminant hepatic failure; a technology whose time has come. Am J Gastroenterol 1993; 88:1876-1881.
9. Chari RS, Collins BH, Magee JC, et al. Brief report: treatment of hepatic failure with ex vivo pig liver perfusion followed by liver transplantation. N Engl J Med 1994; 331:234-237.
10. Olumide F, Eliashiv A, Kralios N, et al. Hepatic support with hepatocyte suspensions in a permeable membrane dialyzer. Surgery 1977; 82:599-606.
11. Matsumura KN, Guevara GR, Houston H, et al. Hybrid bioartificial liver in hepatic failure: preliminary clinical report. Surgery 1987; 101:99-103.
12. Saito S, Sakagami K, Orita K. A new hybrid artificial liver using a combination of hepatocytes and biomatrix. Trans Am Soc Artif Organs 1987; 33:459-462.
13. Jauregui HO, Naik S, Driscoll J, et al. Adult rat hepatocyte cultures as the cellular component of an artificial hybrid liver. In: Paul JP, Galor JDS, Courtney JM, Gilchrist T, eds. Biomaterials in Artificial Organs. London: Macmillan; 1984:130-140.
14. Nyberg SL, Remmel PR, Mann HJ, et al. Primary hepatocytes outperform HepG2 cells as the source of biotransformation functions in a bioartificial liver. Ann Surg 1994; 220:59-67.
15. Sussman NL, Chong MG, Koussayir T, et al. Reversal of fulminant hepatic failure using an extracorporeal liver assist device. Hepatology 1992; 16:60-65.
16. Neuzil DF, Rozga J, Moscioni AD, et al. Use of a novel bioartificial liver in a patient with acute liver insufficiency. Surgery 1993; 113:340-343.
17. Rozga J, Holzman MD, Ro MS, et al. Hybrid bioartificial liver support treatment of animals with severe ischemic liver failure. Ann Surg 1993; 217:502-511.
18. Rozga J, Williams F, Ro MS, et al. Development of a bioartificial liver: properties and function of a hollow-fiber module inoculated with liver cells. Hepatology 1993; 17:256-265.
19. Demetriou AA, Rozga J, Podesta L, et al. Early clinical experience with a bioartificial liver. Scand J Gastroenterol 1995; 30(Suppl 208):111-117.
20. Rozga J, LePage E, Moscioni AD, et al. Clinical use of a bioartificial liver to treat fulminant hepatic failure. Ann Surg 1994; 219:538-546.
21. Watanabe FD, Demetriou AA. Support of acute liver failure patients with a bioartificial liver. J Clin Apheresis 1996; 11:138-142.
22. Kamlot A, Rozga J, Watanabe FD, Demetriou AA. Review: artificial liver support systems. Biotech Bioeng 1996; 50:382-391.
23. Morsiani E, Rozga J, Scott HC, et al. Automated liver cell processing facilitates large-scale isolation and purification of porcine hepatocytes. ASAIO J 1995; 41:155-161.
24. Trey C, Davidson C. The management of fulminant hepatic failure. In: Popper H, Schaffner F, eds. Progress in Liver Disease. New York: Grune & Stratton; 1970:282-298.
25. Record CO, Buxton B, Chase R, et al. Plasma and brain amino acids in fulminant hepatic failure and their relationship to hepatic encephalopathy. Eur J Clin Invest 1976; 6:387-394.
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Language: | English.
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Document Type: | Scientific Papers.
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Journal Subset: | Clinical Medicine.
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ISSN: | 0003-4932
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NLM Journal Code: | 67s, 0372354
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Annotation(s) | |
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