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Clinical introduction of cellular extracorporeal hepatocyte support therapy in the treatment of chronic liver disease

Objective

Brief description : The concept of operation is to work on the basis of an established project, using already developed technology and device prototypes. Research or technological development is not required.
The Project brings together the expertise of clinicians, bioengineers and cell biologists in a truly interdisciplinary approach. Four teams of researchers in four European countries are involved. Clinical applications within centers of excellence in the field of management of liver diseases are planned in order to gain clinical data for several concerted actions between university hospitals, to demonstrate the viability of a new field in medicine, and to interest European industry involved in medical devices and extra-corporeal therapies (dialysis, plasma separation, heart-lung support) with this new technology.
Since the development is in the field of biomedicine and involves biotechnology, the traditional European companies handling with medical extra-corporeal devices have not yet decided to enter this field. The clinical trails in the Project are seen as a vital precursor to attract the interest of European companies with the necessary competencies and resources to carry hybrid liver support into industrial production and dissemination via larger scale clinical studies. Without the results of the Demonstration Project it is unlikely that such companies will be willing to commit substantial resources to the production of such systems. This would form the basis for industry-sponsored larger scale multi-centric European studies. A particular Project aim is to use company demonstration meetings as a tool to convince European industry that uncertainties and financial risks associated with this new field of medical technology are not as high as previously thought and that there is a good opportunity for European industry to enter this innovative field of medical treatment. To enable this, the partnership within the Demonstration Project offers a unique blend of expertise and opportunities to advance hybrid therapy and tissue engineering in Europe.
Plans for the dissemination of Project deliverables and the exploitation of the new technology include in a first step public information's via Internet, multiple European symposia for an audience of scientists, consumer associations, public health services, regulatory bodies, as well as open industrial platforms, followed by open meetings with interested companies to carry hybrid liver support into industrial production. At a second stage congress satellite meetings in the medical community are planned for the dissemination via larger scale clinical studies to possible clinical users.

Keywords : Liver Diseases, Liver Coma, new Therapies, Tissue Engineering, Hybrid organs, Bio-reactors, Liver Cells, Liver Support Systems, Demonstration, Clinical Study.

Liver transplantation is currently the only available effective treatment for chronic liver disease. However, by replacing the old liver, this treatment prevents any chance of spontaneous recovery (liver regeneration). Moreover, a significant number of patients on the waiting list for liver transplantation die before a suitable donor organ can be procured. A bio-artif1cial liver device will lead to improved and more cost effective treatment for end-stage liver disease. As a consequence of such intervention, some patients will recover without the requirement for a liver transplant. This proposal brings together 4 European medical and academic centres of excellence and will lead to a commercial and economic alternative to the costly and major medical intervention of transplantation. When established as a routine treatment, the bio-artificial liver will offer centres without transplantation logistics or centres in less well-developed countries the possibility to treat patients with de-compensated liver disease. The technology will be transferable and could be established in any centre worldwide.

Summary of project objectives:- Prove the technical viability of a new biomedical technology, the hybrid liver support;- Prove the clinical innovation of the new therapy utilising tissue engineering;- Prove the economic advantages of the clinical application of the treatment;- Prove industrial benefits of the commercialisation of the device.

Summary of general project aims:- Demonstration serves as tool for dissemination of the new development;- Demonstration helps to overcome barrier of using biotechnology in medicine;- Demonstration shows compliance of new therapy with regulatory requirements;- Project helps to eliminate medical uncertainties in the field of biomedicine;- Project helps to eliminate industrial uncertainties in the field of biotechnology and tissue engineering.

The reason for submitting this proposal to the EC Programme is the pre-competitive stage of the novel technology, where collaboration between companies and universities have not begun because the financial risks of a clinical introduction appear to be to high for traditional industry in the field of medical technical devices. On the other hand, our strong university partnership may reduce the risks of technological and medical failures within the project. This university partnership involves not only a relatively high level of knowledge and accumulated technology, which enables prototype production, but also commonly accepted clinical expertise in the treatment of liver disease. The interest of potential users may be enhanced after the Demonstration Project has been proven to be successful.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Humboldt-Universität zu Berlin
Address
1,Augustenburger Platz
13353 Berlin
Germany

Participants (3)

HOSPITAL CLINIC BARCELONA
Spain
Address
170,Villaroel 170 Hospital Clinic
08036 Barcelona
Hôpitaux Universitaires de Strasbourg
France
Address
Avenue Molière
67098 Hautepierre
UNIVERSITY OF BIRMINGHAM
United Kingdom
Address
Edgbaston
B15 2TH Birmingham