Skip to main content
italianoIT
European Commission logo print header

Development of DIALIVE, a novel Liver Dialysis Device for the treatment of patients with Acute on Chronic Liver Failure (ACLF)

Descrizione del progetto

DEENESFRITPL

Un nuovo dispositivo per la dialisi epatica

L’insufficienza epatica porta all’accumulo di tossine e aumenta la vulnerabilità del paziente alle infezioni, causando in definitiva un’insufficienza che colpisce più organi e la morte prematura. In tal caso il trapianto di fegato è l’unico metodo per prolungare la vita, ma la sua efficacia è ostacolata dalla scarsità degli organi a disposizione e dagli elevati costi associati a livello sanitario. Per rispondere a questa esigenza clinica insoddisfatta, gli scienziati del progetto ALIVER, finanziato dall’UE, hanno sviluppato un nuovo dispositivo per la dialisi epatica chiamato DIALIVE. I test preclinici del dispositivo hanno già messo in mostra risultati promettenti, migliorando la funzione dell’albumina e riducendo le endotossine. Il progetto ALIVER condurrà studi clinici su DIALIVE in pazienti affetti da insufficienza epatica acuta o cronica allo scopo di ottenere la marcatura CE per un futuro uso clinico.

Obiettivo

Liver disease incidence is increasing and about 170K patients die from liver failure each year in Europe. In liver failure, the accumulation of protein bound toxins and increased susceptibility to infection cause multiorgan failure and death. Liver transplantation is the only treatment known to prolong the life but is limited by availability of organs. A clinically efficacious ‘liver dialysis device’ is an unmet clinical need. The ALIVER Consortium has developed and optimised a novel ‘liver dialysis device’, DIALIVE. The DIALIVE device is protected by world-wide patents and is based upon our discovery that (i) albumin, a circulating protein involved in detoxification is reduced irreversibly in function and (ii) endotoxemia contributes to increased risk of infection in liver failure. DIALIVE incorporates albumin removal and replacement and, endotoxin removal and is a TRL5. In animal models of liver failure, DIALIVE was shown to be easy to use, safe, reduced endotoxemia and, improved albumin and immune function and, prolonged survival. The ALIVER Consortium, which is comprised of experts in liver failure, SMEs and charities proposes to perform clinical trials of DIALIVE in patients with acute on chronic liver failure (ACLF). During the grant period a CE-mark will be obtained and the device will progress to a TRL7/8. Consultation with Regulatory bodies confirms that if the trials are successful, a CE-mark is highly likely. Grifols, a large plasma proteins company is a potential licensee of the technology if the studies proposed by the ALIVER Consortium are positive.
We plan to take the project through regulatory and ethics approval and perform a study to define its safety in ACLF patients in 18 European hospitals; define health economic benefits to the EU and define a reimbursement strategy. The results will be disseminated widely and results exploited to benefit patients, EU healthcare system, create new jobs and grow healthcare Industry in Europe.

Campo scientifico

Parole chiave

Programma(i)

Argomento(i)

Invito a presentare proposte

H2020-SC1-2016-2017

Vedi altri progetti per questo bando

Bando secondario

H2020-SC1-2016-RTD

Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

UNIVERSITY COLLEGE LONDON
Contribution nette de l'UE
€ 1 089 621,24
Indirizzo
GOWER STREET
WC1E 6BT London
Regno Unito

Mostra sulla mappa
Regione
London Inner London — West Camden and City of London
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
€ 1 089 621,24

Partecipanti (11)

Condividi questa pagina

Scarica

Ultimo aggiornamento: 13 Giugno 2023

Il mio booklet

Permalink: https://cordis.europa.eu/project/id/733057/it

European Union, 2024