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

Objective

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 two studies to define its safety and efficacy 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.
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Coordinator

UNIVERSITY COLLEGE LONDON

Address

Gower Street
Wc1e 6bt London

United Kingdom

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 941 912,50

Participants (10)

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YAQRIT LIMITED

United Kingdom

EU Contribution

€ 2 821 450

FAKKEL BVBA

Belgium

EU Contribution

€ 1 263 250

EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF)

Spain

EU Contribution

€ 120 500

ALBUTEC GMBH

Germany

EU Contribution

€ 204 500

EUROPEAN ASSOCIATION FOR THE STUDYOF THE LIVER

Switzerland

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

France

EU Contribution

€ 176 000

SERVICIO MADRILENO DE SALUD

Spain

EU Contribution

€ 116 000

UNIVERSITATSMEDIZIN ROSTOCK

Germany

EU Contribution

€ 140 125

IBM IRELAND LIMITED

Ireland

EU Contribution

€ 261 250

ROYAL FREE LONDON NHS FOUNDATION TRUST

United Kingdom

EU Contribution

€ 433 750

Project information

Grant agreement ID: 733057

Status

Ongoing project

  • Start date

    1 January 2017

  • End date

    30 September 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 7 846 088,75

  • EU contribution

    € 6 478 737,50

Coordinated by:

UNIVERSITY COLLEGE LONDON

United Kingdom