Phases I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease
Fetal hepatocytes have a high regenerative capacity. The aim of the study was to assess treatment safety and clinical efficacy of human fetal liver cell transplantation through splenic artery infusion. Patients with endstage chronic liver disease on the waiting list for liver transplantation were en...
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Format: | Article |
Language: | English |
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SAGE Publishing
2015-08-01
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Series: | Cell Transplantation |
Online Access: | https://doi.org/10.3727/096368914X682422 |
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doaj-648c1eb6680f4081bce25e0194a36d7a |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Giada Pietrosi M.D. Giovanni Vizzini Jorg Gerlach Cinzia Chinnici Angelo Luca Giandomenico Amico Monica D'amato Pier Giulio Conaldi Sergio Li Petri Marco Spada Fabio Tuzzolino Luigi Alio Eva Schmelzer Bruno Gridelli |
spellingShingle |
Giada Pietrosi M.D. Giovanni Vizzini Jorg Gerlach Cinzia Chinnici Angelo Luca Giandomenico Amico Monica D'amato Pier Giulio Conaldi Sergio Li Petri Marco Spada Fabio Tuzzolino Luigi Alio Eva Schmelzer Bruno Gridelli Phases I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease Cell Transplantation |
author_facet |
Giada Pietrosi M.D. Giovanni Vizzini Jorg Gerlach Cinzia Chinnici Angelo Luca Giandomenico Amico Monica D'amato Pier Giulio Conaldi Sergio Li Petri Marco Spada Fabio Tuzzolino Luigi Alio Eva Schmelzer Bruno Gridelli |
author_sort |
Giada Pietrosi M.D. |
title |
Phases I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease |
title_short |
Phases I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease |
title_full |
Phases I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease |
title_fullStr |
Phases I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease |
title_full_unstemmed |
Phases I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease |
title_sort |
phases i-ii matched case-control study of human fetal liver cell transplantation for treatment of chronic liver disease |
publisher |
SAGE Publishing |
series |
Cell Transplantation |
issn |
0963-6897 1555-3892 |
publishDate |
2015-08-01 |
description |
Fetal hepatocytes have a high regenerative capacity. The aim of the study was to assess treatment safety and clinical efficacy of human fetal liver cell transplantation through splenic artery infusion. Patients with endstage chronic liver disease on the waiting list for liver transplantation were enrolled. A retrospectively selected contemporary matched-pair group served as control. Nonsorted raw fetal liver cell preparations were isolated from therapeutically aborted fetuses. The end points of the study were safety and improvement of the Model for End-Stage Liver Disease (MELD) and Child-Pugh scores. Nine patients received a total of 13 intrasplenic infusions and were compared with 16 patients on standard therapy. There were no side effects related to the infusion procedure. At the end of follow-up, the MELD score (mean ± SD) in the treatment group remained stable from baseline (16.0 ± 2.9) to the last observation (15.7 ± 3.8), while it increased in the control group from 15.3 ± 2.5 to 19 ± 5.7 ( p = 0.0437). The Child-Pugh score (mean ± SD) dropped from 10.1 ± 1.5 to 9.1 ± 1.4 in the treatment group and increased from 10.0 ± 1.2 to 11.1 ± 1.6 in the control group ( p = 0.0076). All treated patients with history of recurrent portosystemic encephalopathy (PSE) had no further episodes during 1-year follow-up. No improvement was observed in the control group patients with PSE at study inclusion. Treatment was considered a failure in six of the nine patients (three deaths not liver related, one liver transplant, two MELD score increases) compared with 14 of the 16 patients in the control group (six deaths, five of which were caused by liver failure, four liver transplants, and four MELD score increases). Intrasplenic fetal liver cell infusion is a safe and well-tolerated procedure in patients with end-stage chronic liver disease. A positive effect on clinical scores and on encephalopathy emerged from this preliminary study. |
url |
https://doi.org/10.3727/096368914X682422 |
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doaj-648c1eb6680f4081bce25e0194a36d7a2020-11-25T01:23:55ZengSAGE PublishingCell Transplantation0963-68971555-38922015-08-012410.3727/096368914X682422Phases I-II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver DiseaseGiada Pietrosi M.D.0Giovanni Vizzini1Jorg Gerlach2Cinzia Chinnici3Angelo Luca4Giandomenico Amico5Monica D'amato6Pier Giulio Conaldi7Sergio Li Petri8Marco Spada9Fabio Tuzzolino10Luigi Alio11Eva Schmelzer12Bruno Gridelli13Hepatology Unit, Department of Medicine, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, ItalyHepatology Unit, Department of Medicine, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, ItalyMcGowan Institute for Regenerative Medicine, Departments of Surgery and Bioengineering, University of Pittsburgh, Pittsburgh, PA, USAFondazione Ri.MED, Palermo, ItalyDepartment of Diagnostic and Therapeutics Services, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, ItalyFondazione Ri.MED, Palermo, ItalyFondazione Ri.MED, Palermo, ItalyDepartment of Laboratory Medicine and Advanced Biotechnologies, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, ItalyAbdominal and Transplantation Surgery Unit, Department of Surgery, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, ItalyAbdominal and Transplantation Surgery Unit, Department of Surgery, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, ItalyResearch Office, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, ItalyDepartment of Obstetrics and Gynecology, Civico Hospital, Palermo, ItalyMcGowan Institute for Regenerative Medicine, Departments of Surgery and Bioengineering, University of Pittsburgh, Pittsburgh, PA, USAAbdominal and Transplantation Surgery Unit, Department of Surgery, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, ItalyFetal hepatocytes have a high regenerative capacity. The aim of the study was to assess treatment safety and clinical efficacy of human fetal liver cell transplantation through splenic artery infusion. Patients with endstage chronic liver disease on the waiting list for liver transplantation were enrolled. A retrospectively selected contemporary matched-pair group served as control. Nonsorted raw fetal liver cell preparations were isolated from therapeutically aborted fetuses. The end points of the study were safety and improvement of the Model for End-Stage Liver Disease (MELD) and Child-Pugh scores. Nine patients received a total of 13 intrasplenic infusions and were compared with 16 patients on standard therapy. There were no side effects related to the infusion procedure. At the end of follow-up, the MELD score (mean ± SD) in the treatment group remained stable from baseline (16.0 ± 2.9) to the last observation (15.7 ± 3.8), while it increased in the control group from 15.3 ± 2.5 to 19 ± 5.7 ( p = 0.0437). The Child-Pugh score (mean ± SD) dropped from 10.1 ± 1.5 to 9.1 ± 1.4 in the treatment group and increased from 10.0 ± 1.2 to 11.1 ± 1.6 in the control group ( p = 0.0076). All treated patients with history of recurrent portosystemic encephalopathy (PSE) had no further episodes during 1-year follow-up. No improvement was observed in the control group patients with PSE at study inclusion. Treatment was considered a failure in six of the nine patients (three deaths not liver related, one liver transplant, two MELD score increases) compared with 14 of the 16 patients in the control group (six deaths, five of which were caused by liver failure, four liver transplants, and four MELD score increases). Intrasplenic fetal liver cell infusion is a safe and well-tolerated procedure in patients with end-stage chronic liver disease. A positive effect on clinical scores and on encephalopathy emerged from this preliminary study.https://doi.org/10.3727/096368914X682422 |