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Published, Version of Record (VoR)CC BY-NC V4.0, Open
Journal article
Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial
Liver transplantation, v 24(3), pp 380-393
23 Feb 2018
PMCID: PMC5873437
PMID: 29171941
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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‐derived C3A cells express anti‐inflammatory 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 ≥8 mg/dL, Maddrey's discriminant function ≥ 32, and Model for End‐Stage Liver Disease (MELD) score ≤ 35 were randomized to receive standard of care (SOC) only or 3‐5 days of continuous ELAD treatment plus SOC. After a minimum follow‐up of 91 days, overall survival (OS) was assessed by using a Kaplan‐Meier 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‐to‐treat 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 < 28 (n = 120), ELAD was associated with a trend toward higher OS at 91 days (68.6% versus 53.6%;
P
= .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.
Liver Transplantation 24 380–393 2018
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Details
- Title
- Extracorporeal cellular therapy (ELAD) in severe alcoholic hepatitis: A multinational, prospective, controlled, randomized trial
- Creators
- Julie Thompson - University of Minnesota Medical CenterNatasha Jones - Emory UniversityAli Al‐Khafaji - University of Pittsburgh Medical CenterShahid Malik - University of Pittsburgh Medical CenterDavid Reich - Drexel UniversitySantiago Munoz - Drexel UniversityRoss MacNicholas - Sir Charles Gairdner HospitalTarek Hassanein - Southern California Gastrointestinal and Liver Centers, Coronado, CA.Lewis Teperman - New York University Medical, New York City, NY.Lance Stein - Piedmont Atlanta HospitalAndrés Duarte‐Rojo - University of Arkansas for Medical SciencesRaza Malik - Beth Israel Deaconess Medical CenterTalal Adhami - Cleveland ClinicSumeet Asrani - Baylor University Medical CenterNikunj Shah - Rush University Medical CenterPaul Gaglio - Montefiore Medical CenterAnupama Duddempudi - North Shore University HospitalBrian Borg - University of Mississippi Medical CenterRajiv Jalan - The Royal Free HospitalRobert Brown - Columbia University Medical CenterHeather Patton - University of California San Diego Medical CenterRohit Satoskar - Georgetown UniversitySimona Rossi - Einstein Medical Center PhiladelphiaAmay Parikh - Rutgers, The State University of New JerseyAhmed ElSharkawy - Queen Elizabeth Hospital BirminghamParvez Mantry - Methodist Dallas Medical CenterLinda Sher - University of Southern CaliforniaDavid Wolf - Westchester Medical CenterMarquis Hart - Swedish Medical CenterCharles Landis - University of Washington, HarborviewAlan Wigg - Flinders Medical CentreShahid Habib - University of Arizona Medical CenterGeoffrey McCaughan - Royal Prince Alfred HospitalSteven Colquhoun - Cedars-Sinai Medical CenterAlyssa Henry - Vital TherapiesPatricia Bedard - Vital TherapiesLee Landeen - Vital TherapiesMichael Millis - University of ChicagoRobert Ashley - Vital TherapiesWilliam Frank - Vital TherapiesAndrew Henry - Vital TherapiesJan Stange - University of RostockRam Subramanian - Emory UniversityVTI 208 Study Grp
- Publication Details
- Liver transplantation, v 24(3), pp 380-393
- Publisher
- John Wiley and Sons Inc
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Medicine (Graduate); Surgery
- Web of Science ID
- WOS:000426124000009
- Scopus ID
- 2-s2.0-85042359887
- Other Identifier
- 991019168525804721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Gastroenterology & Hepatology
- Surgery
- Transplantation