A phase II study of human allogeneic liver-derived progenitor cell therapy for acute-on-chronic liver failure and acute decompensation

JHEP Reports - Tập 3 - Trang 100291 - 2021
Frederik Nevens1, Thierry Gustot2, Pierre-François Laterre3, Luc L. Lasser4,5, Lyudmil E. Haralampiev6, Victor Vargas7, Desislava Lyubomirova8, Agustin Albillos9, Mustapha Najimi10, Sébastien Michel11, Ivaylo Stoykov11, Noelia Gordillo11, Yelena Vainilovich11, Virginie Barthel11, Nathalie Clerget-Chossat11, Etienne M. Sokal10,11,12
1Department of Gastroenterology and Hepatology, University Hospitals KU, Leuven, Belgium
2Department of Gastroenterology and Hepato-Pancreatology, C.U.B. Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium
3Intensive Care Unit, Cliniques Universitaires Saint-Luc, UCLouvain, Brussels, Belgium
4Gastroenterology Clinic, CHU Brugmann, Brussels, Belgium
5Department of Hepatogastroenterology, CHU Brugmann, Brussels, Belgium
6Department of Internal Diseases, Multiprofile Hospital for Active Treatment (MEDICA), Ruse, Bulgaria
7Liver Unit, Hospital Vall d'Hebron, Universitat Autònoma Barcelona, CIBERehd, Barcelona, Spain
8Department of Clinical Gastroenterology with Hepatology, Gastroenterology Clinic, University Multiprofile Hospital for Active Treatment “Georgi Stranski”, Pleven, Bulgaria
9Gastroenterology and Hepatology, University Hospital Ramón y Cajal, Madrid, Spain
10UCLouvain, Institute of Experimental and Clinical Research (IREC), Laboratory of Pediatric Hepatology and Cell Therapy (PEDI), Brussels, Belgium
11Promethera Biosciences, Mont-Saint-Guibert, Belgium
12Cliniques Universitaires Saint-Luc, UCLouvain, Pediatric Hepatology & Gastroenterology Unit, Brussels, Belgium

Tài liệu tham khảo

Moreau, 2013, Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis, Gastroenterology, 144, 10.1053/j.gastro.2013.02.042 Arroyo, 2016, Acute-on-chronic liver failure in cirrhosis, Nat Rev Dis Prim, 2, 16041, 10.1038/nrdp.2016.41 Arroyo, 2020, Acute-on-chronic liver failure, N Engl J Med, 382, 2137, 10.1056/NEJMra1914900 Trebicka, 2019, Addressing profiles of systemic inflammation across the different clinical phenotypes of acutely decompensated cirrhosis, Front Immunol, 10, 476, 10.3389/fimmu.2019.00476 Katoonizadeh, 2010, Early features of acute-on-chronic alcoholic liver failure: a prospective cohort study, Gut, 59, 1561, 10.1136/gut.2009.189639 Korf, 2019, Inhibition of glutamine synthetase in monocytes from patients with acute-on-chronic liver failure resuscitates their antibacterial and inflammatory capacity, Gut, 68, 1872, 10.1136/gutjnl-2018-316888 Moreau, 2020, Blood metabolomics uncovers inflammation-associated mitochondrial dysfunction as a potential mechanism underlying ACLF, J Hepatol, 72, 688, 10.1016/j.jhep.2019.11.009 Mahmud, 2019, Incidence and mortality of acute-on-chronic liver failure using two definitions in patients with compensated cirrhosis, Hepatology, 69, 2150, 10.1002/hep.30494 Shi, 2015, Acute-on-chronic liver failure precipitated by hepatic injury is distinct from that precipitated by extrahepatic insults, Hepatology, 62, 232, 10.1002/hep.27795 Li, 2016, Characteristics, Diagnosis and prognosis of acute-on-chronic liver failure in cirrhosis associated to hepatitis B, Sci Rep, 6, 25487, 10.1038/srep25487 2018, EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis, J Hepatol, 69, 406, 10.1016/j.jhep.2018.03.024 Banares, 2013, Extracorporeal albumin dialysis with the molecular adsorbent recirculating system in acute-on-chronic liver failure: the RELIEF trial, Hepatology, 57, 1153, 10.1002/hep.26185 Gerth, 2017, Molecular adsorbent recirculating system can reduce short-term mortality among patients with acute-on-chronic liver failure – a retrospective analysis, Crit Care Med, 45, 1616, 10.1097/CCM.0000000000002562 Sanyal, 2008, A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome, Gastroenterology, 134, 1360, 10.1053/j.gastro.2008.02.014 Chan, 2015, Criteria for liver transplantation in ACLF and outcome, Hepatol Int, 9, 355, 10.1007/s12072-014-9585-x Allen, 2016, Time trends in the health care burden and mortality of acute on chronic liver failure in the United States, Hepatology, 64, 2165, 10.1002/hep.28812 Le Blanc, 2008, Mesenchymal stem cells for treatment of steroid-resistant, severe, acute graft-versus-host disease: a phase II study, Lancet, 371, 1579, 10.1016/S0140-6736(08)60690-X Caplan, 2017, Mesenchymal stem cells: time to change the name!, Stem Cell Transl Med, 6, 1445, 10.1002/sctm.17-0051 Shi, 2012, Human mesenchymal stem cell transfusion is safe and improves liver function in acute-on-chronic liver failure patients, Stem Cell Transl Med, 1, 725, 10.5966/sctm.2012-0034 Lin, 2017, Allogeneic bone marrow-derived mesenchymal stromal cells for hepatitis B virus-related acute-on-chronic liver failure: a randomized controlled trial, Hepatology, 66, 209, 10.1002/hep.29189 Najimi, 2007, Adult-derived human liver mesenchymal-like cells as a potential progenitor reservoir of hepatocytes?, Cell Transpl, 16, 717, 10.3727/000000007783465154 Sokal, 2017, Biodistribution of liver-derived mesenchymal stem cells after peripheral injection in a hemophilia a patient, Transplantation, 101, 1845, 10.1097/TP.0000000000001773 Najar, 2018, Cytokinome of adult-derived human liver stem/progenitor cells: immunological and inflammatory features, Hepatobil Surg Nutr, 7, 331, 10.21037/hbsn.2018.05.01 Lombard, 2019, Human hepatocytes and differentiated adult-derived human liver stem/progenitor cells display in vitro immunosuppressive properties mediated, at least in part, through the nonclassical HLA Class I molecule HLA-G, J Immunol Res, 2019 El-Kehdy, 2017, Immunoprofiling of adult-derived human liver stem/progenitor cells: impact of hepatogenic differentiation and inflammation, Stem Cell Int, 2017 Najimi, 2017, Human liver mesenchymal stem/progenitor cells inhibit hepatic stellate cell activation: in vitro and in vivo evaluation, Stem Cell Res Ther, 8, 131, 10.1186/s13287-017-0575-5 Smets, 2019, Transplantation, 103, 1903, 10.1097/TP.0000000000002605 Scheers, 2012, Adult-derived human liver progenitor cells in long-term culture maintain appropriate gatekeeper mechanisms against transformation, Cell Transpl, 21, 2241, 10.3727/096368912X639026 2016 2013 2008 Kujovich, 2015, Coagulopathy in liver disease: a balancing act, Hematol Am Soc Hematol Educ Program, 2015, 243, 10.1182/asheducation-2015.1.243 Perlee, 2018, Intravenous infusion of human adipose mesenchymal stem cells modifies the host response to lipopolysaccharide in humans: a randomized, single-blind, parallel group, placebo controlled trial, Stem Cells, 36, 1778, 10.1002/stem.2891 Moll, 2015, Different procoagulant activity of therapeutic mesenchymal stromal cells derived from bone marrow and placental decidua, Stem Cell Dev, 24, 2269, 10.1089/scd.2015.0120 Coppin, 2020, Infusion-related thrombogenesis by liver-derived mesenchymal stem cells controlled by anticoagulant drugs in 11 patients with liver-based metabolic disorders, Stem Cell Res Ther, 11, 51, 10.1186/s13287-020-1572-7 Stephenne, 2012, Bivalirudin in combination with heparin to control mesenchymal cell procoagulant activity, PloS One, 7, 10.1371/journal.pone.0042819 Moll, 2019, Intravascular mesenchymal stromal/stem cell therapy product diversification: time for new clinical guidelines, Trend Mol Med, 25, 149, 10.1016/j.molmed.2018.12.006 Moll, 2014, Do cryopreserved mesenchymal stromal cells display impaired immunomodulatory and therapeutic properties?, Stem Cells, 32, 2430, 10.1002/stem.1729 Muciño-Bermejo, 2013, Coagulation abnormalities in the cirrhotic patient, Ann Hepatol, 12, 713, 10.1016/S1665-2681(19)31312-2 Tripodi, 2005, Evidence of normal thrombin generation in cirrhosis despite abnormal conventional coagulation tests, Hepatology, 41, 553, 10.1002/hep.20569 Fisher, 2018, Balanced haemostasis with both hypo- and hyper-coagulable features in critically ill patients with acute-on-chronic-liver failure, J Crit Care, 43, 54, 10.1016/j.jcrc.2017.07.053