{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T03:33:29Z","timestamp":1792035209075,"version":"4.4.0"},"reference-count":20,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","license":[{"start":{"date-parts":[[2018,2,23]],"date-time":"2018-02-23T00:00:00Z","timestamp":1519344000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Liver Transpl"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:p>\n                    Severe alcoholic hepatitis (sAH) is associated with a poor prognosis. There is no proven effective treatment for sAH, which is why early transplantation has been increasingly discussed. Hepatoblastoma\u2010derived C3A cells express anti\u2010inflammatory proteins and growth factors and were tested in an extracorporeal cellular therapy (ELAD) study to establish their effect on survival for subjects with sAH. Adults with sAH, bilirubin \u22658\u2009mg\/dL, Maddrey's discriminant function\u2009\u2265\u200932, and Model for End\u2010Stage Liver Disease (MELD) score\u2009\u2264\u200935 were randomized to receive standard of care (SOC) only or 3\u20105 days of continuous ELAD treatment plus SOC. After a minimum follow\u2010up of 91 days, overall survival (OS) was assessed by using a Kaplan\u2010Meier survival analysis. A total of 203 subjects were enrolled (96 ELAD and 107 SOC) at 40 sites worldwide. Comparison of baseline characteristics showed no significant differences between groups and within subgroups. There was no significant difference in serious adverse events between the 2 groups. In an analysis of the intent\u2010to\u2010treat population, there was no difference in OS (51.0% versus 49.5%). The study failed its primary and secondary end point in a population with sAH and with a MELD ranging from 18 to 35 and no upper age limit. In the prespecified analysis of subjects with MELD\u2009&lt;\u200928 (n\u2009=\u2009120), ELAD was associated with a trend toward higher OS at 91 days (68.6% versus 53.6%;\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u2009=\u2009.08). Regression analysis identified high creatinine and international normalized ratio, but not bilirubin, as the MELD components predicting negative outcomes with ELAD. A new trial investigating a potential benefit of ELAD in younger subjects with sufficient renal function and less severe coagulopathy has been initiated.\n                    <jats:italic toggle=\"yes\">Liver Transplantation 24 380\u2013393 2018<\/jats:italic>\n                    AASLD.\n                  <\/jats:p>","DOI":"10.1002\/lt.24986","type":"journal-article","created":{"date-parts":[[2017,11,24]],"date-time":"2017-11-24T11:12:49Z","timestamp":1511521969000},"page":"380-393","source":"Crossref","is-referenced-by-count":137,"title":["Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial"],"prefix":"10.1097","volume":"24","author":[{"given":"Julie","family":"Thompson","sequence":"first","affiliation":[{"name":"University of Minnesota Medical Center,Minneapolis,MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natasha","family":"Jones","sequence":"additional","affiliation":[{"name":"Emory University School of Medicine,Atlanta,GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Al\u2010Khafaji","sequence":"additional","affiliation":[{"name":"University of Pittsburgh Medical Center,Pittsburgh,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shahid","family":"Malik","sequence":"additional","affiliation":[{"name":"University of Pittsburgh Medical Center,Pittsburgh,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Reich","sequence":"additional","affiliation":[{"name":"Drexel University,Philadelphia,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Santiago","family":"Munoz","sequence":"additional","affiliation":[{"name":"Drexel University,Philadelphia,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross","family":"MacNicholas","sequence":"additional","affiliation":[{"name":"Sir Charles Gairdner Hospital,Nedlands,Western Australia,Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tarek","family":"Hassanein","sequence":"additional","affiliation":[{"name":"Southern California Gastrointestinal and Liver Centers,Coronado,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lewis","family":"Teperman","sequence":"additional","affiliation":[{"name":"New York University Medical,New York City,NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lance","family":"Stein","sequence":"additional","affiliation":[{"name":"Piedmont Atlanta Hospital,Atlanta,GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5377-9295","authenticated-orcid":false,"given":"Andr\u00e9s","family":"Duarte\u2010Rojo","sequence":"additional","affiliation":[{"name":"University of Arkansas for Medical Sciences,Little Rock,AK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raza","family":"Malik","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center,Boston,MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Talal","family":"Adhami","sequence":"additional","affiliation":[{"name":"Cleveland Clinic Foundation in Cleveland,OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumeet","family":"Asrani","sequence":"additional","affiliation":[{"name":"Baylor University Medical Center,Dallas,TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikunj","family":"Shah","sequence":"additional","affiliation":[{"name":"Rush University Medical Center,Chicago,IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Gaglio","sequence":"additional","affiliation":[{"name":"Montefiore Medical Center,Bronx,NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anupama","family":"Duddempudi","sequence":"additional","affiliation":[{"name":"North Shore University Hospital,Manhasset,NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Borg","sequence":"additional","affiliation":[{"name":"University of Mississippi Medical Center,Jackson,MS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajiv","family":"Jalan","sequence":"additional","affiliation":[{"name":"Royal Free Hospital,London,United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Brown","sequence":"additional","affiliation":[{"name":"Columbia University Medical Center,New York City,NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Patton","sequence":"additional","affiliation":[{"name":"University of California, San Diego Medical Center,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohit","family":"Satoskar","sequence":"additional","affiliation":[{"name":"Georgetown University,Washington,DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Rossi","sequence":"additional","affiliation":[{"name":"Albert Einstein Medical Center,Philadelphia,PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amay","family":"Parikh","sequence":"additional","affiliation":[{"name":"Rutgers University Medical Center,New Brunswick,NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"ElSharkawy","sequence":"additional","affiliation":[{"name":"Queen Elizabeth Hospital\/University of Birmingham,Birmingham,United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parvez","family":"Mantry","sequence":"additional","affiliation":[{"name":"Methodist Dallas Medical Center,Dallas,TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Sher","sequence":"additional","affiliation":[{"name":"University of Southern California,Los Angeles,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Wolf","sequence":"additional","affiliation":[{"name":"Westchester Medical Center,Valhalla,NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marquis","family":"Hart","sequence":"additional","affiliation":[{"name":"Swedish Medical Center,Seattle,WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Landis","sequence":"additional","affiliation":[{"name":"University of Washington, Harborview,Seattle,WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Wigg","sequence":"additional","affiliation":[{"name":"Flinders Medical Centre, Adelaide,Bedford Park,South Australia,Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shahid","family":"Habib","sequence":"additional","affiliation":[{"name":"University of Arizona Medical Center,Tucson,AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geoffrey","family":"McCaughan","sequence":"additional","affiliation":[{"name":"Royal Prince Alfred Hospital,Camperdown,New South Wales,Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Colquhoun","sequence":"additional","affiliation":[{"name":"Cedars\u2010Sinai Medical Center,Los Angeles,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alyssa","family":"Henry","sequence":"additional","affiliation":[{"name":"Vital Therapies Inc.,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Bedard","sequence":"additional","affiliation":[{"name":"Vital Therapies Inc.,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lee","family":"Landeen","sequence":"additional","affiliation":[{"name":"Vital Therapies Inc.,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Millis","sequence":"additional","affiliation":[{"name":"University of Chicago,Chicago,IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Ashley","sequence":"additional","affiliation":[{"name":"Vital Therapies Inc.,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Frank","sequence":"additional","affiliation":[{"name":"Vital Therapies Inc.,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Henry","sequence":"additional","affiliation":[{"name":"Vital Therapies Inc.,San Diego,CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Stange","sequence":"additional","affiliation":[{"name":"Vital Therapies Inc.,San Diego,CA"},{"name":"Center for Internal Medicine, University of Rostock,Rostock,Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ram","family":"Subramanian","sequence":"additional","affiliation":[{"name":"Emory University School of Medicine,Atlanta,GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the VTI\u2010208 Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2018,2,23]]},"reference":[{"key":"lt24986-bib-0001-20240115","doi-asserted-by":"crossref","first-page":"785","DOI":"10.1053\/j.gastro.2016.02.042","article-title":"Standard definitions and common data elements for clinical trials in patients with alcoholic hepatitis: recommendation from the NIAAA alcoholic hepatitis consortia","volume":"150","year":"2016","journal-title":"Gastroenterology"},{"key":"lt24986-bib-0002-20240115","doi-asserted-by":"crossref","first-page":"1572","DOI":"10.1053\/j.gastro.2011.09.002","article-title":"Alcoholic liver disease: Pathogenesis and new therapeutic targets","volume":"141","year":"2011","journal-title":"Gastroenterology"},{"key":"lt24986-bib-0003-20240115","doi-asserted-by":"crossref","first-page":"2758","DOI":"10.1056\/NEJMra0805786","article-title":"Alcoholic hepatitis","volume":"360","year":"2009","journal-title":"N Engl J Med"},{"key":"lt24986-bib-0004-20240115","doi-asserted-by":"crossref","first-page":"724","DOI":"10.1111\/liv.12559","article-title":"Systemic inflammation is associated with increased intrahepatic resistance and mortality in alcohol\u2010related acute\u2010on\u2010chronic liver failure","volume":"35","year":"2015","journal-title":"Liver Int"},{"key":"lt24986-bib-0005-20240115","first-page":"282","article-title":"Prednisolone or pentoxifylline for alcoholic hepatitis","volume":"373","year":"2015","journal-title":"N Engl J Med"},{"key":"lt24986-bib-0006-20240115","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1056\/NEJMc1506342","article-title":"Prednisolone or pentoxifylline for alcoholic hepatitis","volume":"373","year":"2015","journal-title":"N Engl J Med"},{"key":"lt24986-bib-0007-20240115","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1056\/NEJMc1506342","article-title":"Prednisolone or pentoxifylline for alcoholic hepatitis","volume":"373","year":"2015","journal-title":"N Engl J Med"},{"key":"lt24986-bib-0008-20240115","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1111\/liv.13248","article-title":"Liver transplantation for patients with alcoholic hepatitis","volume":"37","year":"2017","journal-title":"Liver Int"},{"key":"lt24986-bib-0009-20240115","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1097\/SLA.0000000000001994","article-title":"Liver transplantation for alcoholic hepatitis","volume":"265","year":"2017","journal-title":"Ann Surg"},{"key":"lt24986-bib-0010-20240115","doi-asserted-by":"crossref","first-page":"4423","DOI":"10.3748\/wjg.v21.i14.4423","article-title":"Six month abstinence rule for liver transplantation in sever alcoholic liver disease","volume":"21","year":"2015","journal-title":"World J Gastroenterol"},{"key":"lt24986-bib-0011-20240115","doi-asserted-by":"crossref","first-page":"24","DOI":"10.3748\/wjg.v22.i1.24","article-title":"Multipotent mesenchymal stromal cells: a promising strategy to manage alcoholic liver disease","volume":"22","year":"2016","journal-title":"World J Gastroenterol"},{"key":"lt24986-bib-0012-20240115","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1186\/s13287-017-0541-2","article-title":"Autologouse bone marrow\u2010derived cell transplantation in decompensated alcoholic liver disease: what is the impact on liver histology and gene expression patterns?","volume":"8","year":"2017","journal-title":"Stem Cell Res Ther"},{"key":"lt24986-bib-0014-20240115","first-page":"1071A","article-title":"ELAD VTL C3A cells may impact liver regeneration through secreted factors","volume":"62","year":"2015","journal-title":"Hepatology"},{"key":"lt24986-bib-0015-20240115","first-page":"147","article-title":"Bilirubin Improvement correlates with 90-day survival with use of the ELAD\u00ae system in a randomized, controlled study of subjects with acute alcoholic hepatitis or acute decompensation of cirrhosis [abstract]","year":"2013","journal-title":"Am J Transplant"},{"key":"lt24986-bib-0016-20240115","doi-asserted-by":"crossref","first-page":"353","DOI":"10.1002\/hep.20503","article-title":"MELD accurately predicts mortality in patients with alcoholic hepatitis","volume":"41","year":"2005","journal-title":"Hepatology"},{"issue":"suppl 1","key":"lt24986-bib-0017-20240115","first-page":"S21","article-title":"Extracorporeal liver support\u2010albumin dialysis with the Molecular Adsorbent Recirculating System (MARS)","volume":"10","year":"2011","journal-title":"Ann Hepatol"},{"key":"lt24986-bib-0018-20240115","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1016\/j.jhep.2015.08.018","article-title":"High\u2010volume plasma exchange in patients with acute liver failure: an open randomised controlled trial","volume":"64","year":"2016","journal-title":"J Hepatol"},{"key":"lt24986-bib-0019-20240115","doi-asserted-by":"crossref","first-page":"1348","DOI":"10.1002\/hep.21607","article-title":"The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids","volume":"45","year":"2007","journal-title":"Hepatology"},{"key":"lt24986-bib-0020-20240115","doi-asserted-by":"crossref","first-page":"2189","DOI":"10.1056\/NEJMsr077003","article-title":"Statistics in medicine\u2010\u2010reporting of subgroup analysis in clinical trials","volume":"357","year":"2007","journal-title":"N Engl J Med"},{"key":"lt24986-bib-0021-20240115","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1002\/hep.23258","article-title":"Alcoholic liver disease","volume":"51","year":"2010","journal-title":"Hepatology"}],"container-title":["Liver Transplantation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Flt.24986","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lt.24986","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/lt.24986","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.lww.com\/01445473-201803000-00010","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,14]],"date-time":"2024-01-14T20:11:56Z","timestamp":1705263116000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.lww.com\/01445473-201803000-00010"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,2,23]]},"references-count":20,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2018]]}},"URL":"https:\/\/doi.org\/10.1002\/lt.24986","relation":{},"ISSN":["1527-6465","1527-6473"],"issn-type":[{"value":"1527-6465","type":"print"},{"value":"1527-6473","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,2,23]]}}}