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Personalized minimization of immunosuppression after solid organ transplantation by biomarker-driven stratification of patients to improve long-term outcome and health-economic data of transplantation

Objective

Organ transplantation has emerged as the “gold standard” therapy for end-stage organ failure. Incomplete control of chronic allograft injury but also the adverse effects of long-term immunosuppression (IS) continue to challenge the long-term success of transplantation. The paradigm is shifting from increasing “net”-IS by novel drugs to the concept of minimizing long-term IS as early as possible. However, data were almost completely generated by “trial-and-error” observational studies. It suggests an unmet need to stratify transplant (Tx) patients regarding their immunological responsiveness to the allograft and their respective individual need of IS. The central focus of the project is the implementation of biomarker-driven strategies for personalizing IS to improve the long-term outcome and to decrease the adverse effects and costs of chronic IS. This includes 5 innovative investigator-driven biomarker clinical trials designed by the consortium with >1800 (screening) / 1000 (trial) patients. The following issues will be addressed: -targeted complete/partial weaning of standard IS in long-term stable liver and kidney Tx patients identified as “operationally tolerant” by recently developed biomarker panels-prevention of CNI-based standard IS in low-responder kidney Tx recipients by perioperative biomarker-based stratification-shifting high to low-responder kidney Tx patients suitable for early minimisation by the recently explored selective targeting of alloreactive effector/memory T cells -implementing new biomarker candidates supporting personalized IS within the clinical trials-analysing the health-economic impact of biomarker-guided personalized IS -studying the mechanisms behind successful weaning (regulation/effector balance) -disseminating the results and developing commercialisation by partnering with SME/industry. The project will take advantage and exploit recent research findings–Indices of Tolerance (IOT) and RISET but also of other international groups.

Field of science

  • /medical and health sciences/clinical medicine/transplantation

Call for proposal

FP7-HEALTH-2012-INNOVATION-1
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Address
Chariteplatz 1
10117 Berlin
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 344 168
Administrative Contact
Eveline Fräßdorf (Ms.)

Participants (16)

CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES
France
EU contribution
€ 500 000
Address
Allee De L'ile Gloriette 5
44093 Nantes
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sophie Brouard (Dr.)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 294 600
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Linda Pialek (Ms.)
KING'S COLLEGE LONDON
United Kingdom
EU contribution
€ 849 660
Address
Strand
WC2R 2LS London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Labbett (Mr.)
INSTITUT CATALA DE LA SALUT
Spain
EU contribution
€ 500 000
Address
Gran Via De Les Corts Catalanes 587
08007 Barcelona
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Laia Lagunas (Ms.)
Institut klinické a experimentální mediciny
Czechia
EU contribution
€ 500 000
Address
Videnska 1958/9
14021 Prague 4
Activity type
Research Organisations
Administrative Contact
Tomáš Linhart
ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Netherlands
EU contribution
€ 201 340
Address
Meibergdreef 15
1105AZ Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Frank J.M. Groen (Dr.)
KLINIKUM DER UNIVERSITAET REGENSBURG
Germany
EU contribution
€ 201 600
Address
Frans Josef Strauss Allee 11
93053 Regensburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Elisabeth Geiger (Mrs.)
UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Germany
EU contribution
€ 201 600
Address
Martinistrasse 52
20251 Hamburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Bjoern Nashan (Prof.)
CELLOGIC GMBH
Germany
EU contribution
€ 199 200
Address
Niedstrasse 21
12159 Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Malte Pietzsch (Dr.)
IMMUNOTECH SAS
France
EU contribution
€ 114 400
Address
Avenue Jean De Lattre De Tassigny 130
13009 Marseille
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Basile Wilhelem (Dr.)
Genome Identification Diagnostics GmbH
Germany
EU contribution
€ 611 000
Address
Ebinger Str. 4
72479 Strassberg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Rosemarie Preyer (Mrs.)
MILENIA BIOTEC GMBH
Germany
EU contribution
€ 89 832
Address
Versailler Strasse 1
35394 Giessen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ralf Dostatni (Dr.)
BRISTOL-MYERS SQUIBB GMBH & CO. KGAA

Participation ended

Germany
Address
Arnulfstrasse 29
80636 Munich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Michael Anton Hack (Dr.)
ASTELLAS PHARMA EUROPE LTD
United Kingdom
EU contribution
€ 76 000
Address
2000 Hillswood Drive
KT16 0RS Chertsey
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Morne Voight (Dr.)
ALTA RICERCA E SVILUPPO IN BIOTECNOLOGIE SRLU
Italy
EU contribution
€ 229 600
Address
Via Fiorentina 151
53100 Siena
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Cristiana Tozzi (Dr.)
TEVA PHARMACEUTICALS EUROPE B.V.
Netherlands
EU contribution
€ 76 000
Address
Piet Heinkade 107
1019 GM Amsterdam
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Carla-Maria Brandes (Dr.)