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The bioreactors developed by our group were first introduced into a clinical setting in a phase I study utilizing primary porcine cells. Eight patients with acute liver failure, coma stage II-IV, were treated to bridge the waiting time for an organ transplant while listed at Eurotransplant as high-urgency cases. The condition of all patients stabilized during the course of treatment, and the patient and organ survival rates remain at 100%.
After advancing to the use of primary human liver cells and the development of the Modular Extracorporeal Liver Support concept a further clinical pilot study was performed on 9 patients . 2/2 patients with acute liver failure (ALF) were successfully bridged to liver transplantation (LTx). 2/2 patients with acute-on-chronic (AoC) liver failure were successfully bridged to LTx. One of these patients died 3 weeks after transplantation following multi-organ failure. Two patients with AoC liver failure were not eligible for LTx due to continuing alcohol consumption: they were supported during a period of acute deterioration and one of them died three weeks after the last treatment. 3/3 patients were successfully bridged to re-transplantation after primary non-function of their liver graft. One patient with initial poor function was treated to recovery over periods of 73 h and 71 h. Another patient was totally hepatectomized and was subsquently supported over a period of 24 hours prior to re-transplantation. The overall treatment time was 7-144 hours. No adverse events were observed. In all cases of acute liver failure the patient's neurological status improved during treatment. After oligo-anuric kidney failure, recovery was noted and a slight improvement of coagulation status was seen.
- Sauer IM, Kardassis D, Zeillinger K, Pascher A, Gruenwald A, Pless G, Irgang M, Kraemer M, Puhl G, Frank J, MüllerAR , Steinmüller T, Denner J, Neuhaus P, Gerlach JC: Clinical extracorporeal hybrid liver support – phase I study with primary porcine liver cells. Xenotransplantation; 2003, 10: 460-469
- Irgang M, Sauer IM, Karlas A, Zeilinger K, Gerlach JC, Kurth R, Neuhaus P, Denner J: Porcine endogenous retroviruses (PERVs): No infection in patients treated with a bioreactor based on porcine liver cells. Clinical Virology 2003, J Clin Virol; 2003, 28(2): 141-154
- Gerlach J, Zeilinger K, Sauer IM, Mieder T, Nauman G, Grünwald A, Pless G, Holand A, Mas A, Vienken J, Neuhaus P. Extracorporeal liver support: Porcine or human cell based systems? Int J Artif Org 2002; 25 (10): 1013-1019
- Sauer I, Gerlach J. Modular extracorporeal liver support. Art Org 2002; 26:703-706
- Sauer I, Gerlach J. Concept of modular extracorporeal liver support for treatment of acute hepatic failure. Journal of Metabolic Brain Disease 2002; 17 (4): 477-484
- Sauer IM, Zeilinger K, Obermayer N, Pless G, Pascher A, Mieder T, Roth S, Goetz M, Kardassis D, Mas A, Neuhaus P, Gerlach JC. Primary human liver cells as source for modular extracorporeal liver support – a preliminary report. Int J Art Org 2002; 25 (10): 1001-1006
- Sauer IM, Zeilinger K, Pless G, Kardassis D, Theruvath T, Pascher A, Mueller AR, Steinmueller T, Neuhaus P, Gerlach JC: Extracorporeal Liver Support based on Human Liver Cells and Albumin Dialysis – Treatment of a Patient with Primary Graft Non-Function. Journal of Hepatology 2003; 39(4): 649-653