Delving into the Latest Updates on Extracorporeal Hepatocyte-based Therapy (Vital Therapies, Inc.) with Synapse

Overview

Basic Info

Drug Type

Cell therapy

Synonyms

ELAD, Extracorporeal bio-artificial liver, Extracorporeal hepatocyte-based therapy

+ [2]

Target-

Mechanism

Cell replacements

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [2]

Active Indication-

Inactive Indication

Hepatitis, AlcoholicImmunoblastic Lymphadenopathy

Originator Organization

Vital Therapies, Inc.

Active Organization-

Inactive Organization

Vital Therapies, Inc.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.
The secondary objective is to evaluate the proportion of survivors at Study Day 91 using a chi-squared test.

Start Date01 Jan 2016

Sponsor / Collaborator

Vital Therapies, Inc.

100 Clinical Results associated with Extracorporeal Hepatocyte-based Therapy (Vital Therapies, Inc.)

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100 Translational Medicine associated with Extracorporeal Hepatocyte-based Therapy (Vital Therapies, Inc.)

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100 Patents (Medical) associated with Extracorporeal Hepatocyte-based Therapy (Vital Therapies, Inc.)

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5

Literatures (Medical) associated with Extracorporeal Hepatocyte-based Therapy (Vital Therapies, Inc.)

01 Dec 2021·Annals of Intensive CareQ2 · MEDICINE

Uncertainty in the impact of liver support systems in acute-on-chronic liver failure: a systematic review and network meta-analysis

Q2 · MEDICINE

ReviewOA

Author: Szakács, Zsolt ; Hegyi, Péter ; Molnár, Zsolt ; Erőss, Bálint ; Mitzner, Steffen ; Ocskay, Klementina ; Stange, Jan ; Pár, Gabriella ; Kanjo, Anna ; Gede, Noémi

AbstractBackgroundThe role of artificial and bioartificial liver support systems in acute-on-chronic liver failure (ACLF) is still controversial. We aimed to perform the first network meta-analysis comparing and ranking different liver support systems and standard medical therapy (SMT) in patients with ACLF.MethodsThe study protocol was registered with PROSPERO (CRD42020155850). A systematic search was conducted in five databases. We conducted a Bayesian network meta-analysis of randomized controlled trials assessing the effect of artificial or bioartificial liver support systems on survival in patients with ACLF. Ranking was performed by calculating the surface under cumulative ranking (SUCRA) curve values. The RoB2 tool and a modified GRADE approach were used for the assessment of the risk of bias and quality of evidence (QE).ResultsIn the quantitative synthesis 16 trials were included, using MARS®, Prometheus®, ELAD®, plasma exchange (PE) and BioLogic-DT®. Overall (OS) and transplant-free (TFS) survival were assessed at 1 and 3 months. PE significantly improved 3-month OS compared to SMT (RR 0.74, CrI: 0.6–0.94) and ranked first on the cumulative ranking curves for both OS outcomes (SUCRA: 86% at 3 months; 77% at 1 month) and 3-month TFS (SUCRA: 87%) and second after ELAD for 1-month TFS (SUCRA: 76%). Other comparisons did not reach statistical significance. QE was moderate for PE concerning 1-month OS and both TFS outcomes. Other results were of very low certainty.ConclusionPE seems to be the best currently available liver support therapy in ACLF regarding 3-month OS. Based on the low QE, randomized trials are needed to confirm our findings for already existing options and to introduce new devices.

01 Feb 2001·Transplantation ProceedingsQ4 · MEDICINE

Bioartificial liver support: report of the longest continuous treatment with human hepatocytes

Q4 · MEDICINE

Article

Author: T.W Faust ; S Trevino ; D Traglia ; J.M Millis ; G Dane ; R Johnson ; P Maguire ; J Brotherton ; C Conlin ; D.C Cronin ; H Conjeevaram

The extracorporeal liver assist device (ELAD), which uses 400 g of human hepatocytes and continuous therapy, was evaluated in a patient with idiopathic fulminant hepatic failure.The patient was continuously treated longer than any patient previously reported (108 h).ELAD therapy was safe for over 100 h of continuous therapy.Significant clin. hemodynamic and cardiopulmonary improvement was observedBiochem. evidence of improved hepatic function was found toward the end of therapy.Therapy with the inclusion of ELAD support allowed successful transplantation.

01 Dec 1996·HepatologyQ1 · MEDICINE

Pilot-controlled trial of the extracorporeal liver assist device in acute liver failure

Q1 · MEDICINE

Article

Author: P G Langley ; J A Wendon ; N L Sussman ; J Dunne ; R D Hughes ; G T Gislason ; A J Ellis ; J H Kelly ; R Williams

The objective of this pilot controlled study was to evaluate the extracorporeal liver assist device (ELAD) in patients with acute liver failure who were judged to still have a significant chance of survival (approximately 50%) and in those who had already fulfilled criteria for transplantation. Twenty-four patients were divided into two groups, 17 with a potentially recoverable lesion (group I) and 7 listed for transplantation (group II), and then randomly allocated to ELAD haemoperfusion or control. The median period of ELAD haemoperfusion was 72 hours (range 3-168 h). Biocompatibility of the device was good, with no acceleration in platelet consumption, and haemodynamic stability was maintained. Two patients were withdrawn from the study because of worsening of preexisting disseminated intravascular coagulation in one case and a hypersensitivity reaction in the other. Deterioration with respect to encephalopathy grade was more frequent in the control patients, 7 of 12 (58%), than in the ELAD-treated patients, 3 of 12 (25%). In group I where survival for the ELAD cases was 7 of 9 (78%), there was a higher than expected survival in the controls, 6 of 8 (75%). For group II cases, survival was 1 of 3 (33%) for the ELAD-treated patients, and 1 of 4 (25%) for the controls. Both of the survivors underwent transplantation. Assessment of additive function for the device revealed an improvement in galactose elimination capacity after 6 hours of haemoperfusion. Based on the results of this pilot-controlled trial, better indices of prognosis will be required, in addition to those used to select for transplantation, if patients at an earlier stage of clinical deterioration are to be included in future studies.

100 Deals associated with Extracorporeal Hepatocyte-based Therapy (Vital Therapies, Inc.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immunoblastic Lymphadenopathy	Phase 3	ES	Vital Therapies, Inc.	01 Jan 2016
Immunoblastic Lymphadenopathy	Phase 3	AT	Vital Therapies, Inc.	01 Jan 2016
Hepatitis, Alcoholic	Phase 3	ES	Vital Therapies, Inc.	01 Feb 2013
Hepatitis, Alcoholic	Phase 3	US	Vital Therapies, Inc.	01 Feb 2013
Hepatitis, Alcoholic	Phase 3	US	Vital Therapies, Inc.	01 Feb 2013
Hepatitis, Alcoholic	Phase 3	ES	Vital Therapies, Inc.	01 Feb 2013
Hepatitis, Alcoholic	Phase 3	GB	Vital Therapies, Inc.	01 Feb 2013
Hepatitis, Alcoholic	Phase 3	AU	Vital Therapies, Inc.	01 Feb 2013
Hepatitis, Alcoholic	Phase 3	AU	Vital Therapies, Inc.	01 Feb 2013
Hepatitis, Alcoholic	Discovery	GB	Vital Therapies, Inc.	01 Feb 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01829347 (CTgov)	Phase 3	Hepatitis, Alcoholic	18	Standard of Care treatment+ELAD (ELAD (Plus Standard of Care))	zgvhfjisnr(fkpvwwjvvf) = naenzfoaaj ytqpnsamce (azgfkfludj, kyifctdlfy - jcnloyiybm) View more	-	19 Feb 2019
				Standard of Care treatment (Standard of Care (Control))	zgvhfjisnr(fkpvwwjvvf) = ijgkstbjxd ytqpnsamce (azgfkfludj, pmiedljaey - xbalpdbdhu) View more
NCT01471028 (CTgov)	Phase 3	Hepatitis, Alcoholic	203	ELAD treatment (ELAD Treatment)	lfabaorlkm(mbtjmbrtix) = xwhhjwgxjz pjvtictwqw (ccwrnyicga, nmnmmeqlub - sugscjkvqx) View more	-	15 Feb 2019
				Standard of care (Control) (Standard of Care (Control))	lfabaorlkm(mbtjmbrtix) = bhjcegwoyt pjvtictwqw (ccwrnyicga, wufcxqtbez - bbhjkgflcc) View more
NCT02612428 (CTgov)	Phase 3	Hepatitis, Alcoholic \| Immunoblastic Lymphadenopathy	151	ELAD System (ELAD System)	dzbwkvzqil(gapjyuzhkr) = xkiwkpzezx uktuikaqap (lephboujjs, mmesltvhvw - kwuxctfays) View more	-	25 Jan 2019
				Standard of Care (Control) (Standard of Care (Control))	dzbwkvzqil(gapjyuzhkr) = loraxtcxkv uktuikaqap (lephboujjs, uhkmzumpxs - ttvulqnagn) View more