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Repair of tissue and organ damage in refractory chronic graft versus host disease after hematopoietic stem cell transplantation by the infusion of purified allogeneic donor regulatory T lymphocytes

Objective

Our proposal encompasses parallel clinical trials addressing the feasibility and the effectiveness of donor-derived regulatory T cells (Treg) as a therapeutic agent in the treatment and prevention of tissue and organ damage resulting from graft versus host disease (GVHD) after hematopoietic stem cell transplantation (HSCT).
We propose a collaborative clinical study in which Treg therapy for GHVD is the common dominator. However, by bringing together several clinical centers with expertise in this area, we are also having the opportunity to simultaneously address other issues that would not otherwise be addressable by each clinical center on its own. Firstly, by using different Treg preparation strategies, we will be able to determine whether ex vivo isolated Treg are sufficient or whether in vitro expansion and subsequently higher dosages are required. Secondly, we will investigate if sole Treg infusion is effective or if rather co-administration of therapeutic agents that are likely to induce Treg survival and expansion in vivo (rapamycin; IL-2) is required for a successful response to Treg therapy.
The studies on GVHD treatment outcome will be pursued together with a detailed analysis of immune monitoring, comprising T cell receptor clonotype tracking and tissue regeneration markers, in order to further understand the mechanisms underlying the therapeutic and regenerative potential of Treg cells.
Our consortium has developed a concerted approach to the topic of Treg therapy in GVHD. This is a unique opportunity to determine the validity of this cellular immunotherapy approach in GVHD prevention and treatment, with potential for a significant impact on patient quality of life, survival rate and ultimately on the quality of health care provided.

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2014-single-stage

Coordinator

INSTITUTO DE MEDICINA MOLECULAR JOAO LOBO ANTUNES
Net EU contribution
€ 1 886 979,18
Address
Avenida Prof Egas Moniz
1649 028 Lisboa
Portugal

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Region
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Activity type
Research Organisations
Other funding
€ 0,00

Participants (8)

KLINIKUM DER UNIVERSITAET REGENSBURG
Germany
Net EU contribution
€ 1 423 823,75
Address
Frans Josef Strauss Allee 11
93053 Regensburg

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Region
Bayern Oberpfalz Regensburg, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITE DE LIEGE
Belgium
Net EU contribution
€ 241 742,78
Address
Place Du 20 Aout 7
4000 Liege

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Region
Région wallonne Prov. Liège Arr. Liège
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
IRCCS AZIENDA OSPEDALIERO- UNIVERSITARIA DI BOLOGNA
Italy
Net EU contribution
€ 627 452,50
Address
Via Albertoni 15
40138 Bologna

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Region
Nord-Est Emilia-Romagna Bologna
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00
MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG DER WISSENSCHAFTEN EV
Germany
Net EU contribution
€ 741 335,00
Address
Hofgartenstrasse 8
80539 Munchen

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Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Research Organisations
Other funding
€ 0,00
ALACRIS THERANOSTICS GMBH
Germany
Net EU contribution
€ 277 500,00
Address
Max Planck Strasse 3
12489 Berlin

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Berlin Berlin Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
THE UNIVERSITY OF LIVERPOOL
United Kingdom
Net EU contribution
€ 246 077,50
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool

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Region
North West (England) Merseyside Liverpool
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG

Participation ended

Germany
Net EU contribution
€ 88 919,29
Address
Oskar Von Miller Ring 29
80333 Muenchen
SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Bayern Oberbayern München, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
SERVICIO ANDALUZ DE SALUD
Spain
Net EU contribution
€ 365 420,00
Address
Avenida De La Constitucion 18
41071 Sevilla

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Region
Andalucía Sevilla
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 0,00