Phase I Clinical Trial with the AMC-Bioartificial Liver-Reference-Cited by-同舟云学术

Phase I Clinical Trial with the AMC-Bioartificial Liver

Published:2002-10 Issue:10 Volume:25 Page:950-959
ISSN:0391-3988
Container-title:The International Journal of Artificial Organs
language:en
Short-container-title:Int J Artif Organs

Author:

Van De Kerkhove M.-P.¹,Di Florio E.²,Scuderi V.²,Mancini A.³,Belli A.³,Bracco A.³,Dauri M.⁴,Tisone G.⁴,Di Nicuolo G.⁵,Amoroso P.⁶,Spadari A.⁷,Lombardi G.⁸,Hoekstra R.¹,Calise F.²,Chamuleau R. A.F.M.⁹

Affiliation:

1. Surgical Laboratory, Department of Surgery, Academic Medical Center, University of Amsterdam, Amsterdam - The Netherlands

2. Liver Transplantation Unit, Department of Surgery, Cardarelli Hospital, Naples - Italy

3. Centro di Biotecnologie A.O. Cardarelli, Naples - Italy

4. Liver Transplantation Unit, St. Eugenio Hospital, Rome - Italy

5. Virology Laboratory, D. Cotugno Hospital, Naples - Italy

6. VI Division of Infectious Diseases, D. Cotugno Hospital, Naples - Italy

7. Department of Veterinary Medicine, University of Bologna, Bologna - Italy

8. Istituto Zooprofilattico, Brescia - Italy

9. Department of Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam - The Netherlands

Abstract

Recently a bio-artificial liver (BAL) system has been developed at the Academic Medical Center (AMC) of Amsterdam to bridge patients with acute liver failure (ALF) to orthotopic liver transplantation (OLT). After successful testing of the AMC-BAL in rodents and pigs with ALF, a phase I study in ALF patients waiting for (OLT) was started in Italy. We present the safety outcome of the first 7 patients aged 21–56 years with coma grade III or IV. The total AMC-BAL treatment time ranged from 8 to 35 hours. Three patients received 2 treatments with two different BAL's within three days. Six of the 7 patients were successfully bridged to OLT. One patient showed improved liver function after two treatments and did not need OLT. No severe adverse events of the BAL treatment were noted. Conclusion Treatment of ALF patients with the AMC-BAL is a safe and feasible technique to bridge the waiting time for an adequate liver-graft.

Publisher

SAGE Publications

Subject

Biomedical Engineering,Biomaterials,General Medicine,Medicine (miscellaneous),Bioengineering

Link

http://journals.sagepub.com/doi/pdf/10.1177/039139880202501009

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