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TRACE SIGNED

Transfer of multivirus-specific T-cells following transplantation

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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 TRACE project word cloud

Explore the words cloud of the TRACE project. It provides you a very rough idea of what is the project "TRACE" about.

gmp    trials    survival    none    protection    receiving    adenovirus    cell    threatening    basic    daily    expertise    patients    immunity    self    thereby    overcome    individualized    barr    variety    translation    toxic    manufacturing    immunotherapy    milestone    health    lack    allogeneic    first    standard    refractory    qualification    restored    intensive    instead    cellular    efficacy    routine    standardized    facilities    viral    physiological    proven    infection    adoptive    quality    life    personalized    national    industrial    treatment    structural    limited    protective    safe    individuals    cmv    transplantation    virus    saving    infections    human    compromized    sct    deficient    post    prospective    unsolved    transfer    time    stem    safety    hurdles    adv    epstein    economics    body    ebv    immune    trial    regulatory    rare    hsct    diseases    curative    medicine    procedure    clinical    lacking    cytomegalovirus    breakthrough    trace    prove    excellence    agents    options   

Project "TRACE" data sheet

The following table provides information about the project.

Coordinator
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN 

Organization address
address: GESCHWISTER SCHOLL PLATZ 1
city: MUENCHEN
postcode: 80539
website: www.uni-muenchen.de

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Germany [DE]
 Project website http://www.trace-study.de
 Total cost 6˙000˙000 €
 EC max contribution 6˙000˙000 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2017-Two-Stage-RTD
 Funding Scheme RIA
 Starting year 2018
 Duration (year-month-day) from 2018-01-01   to  2022-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN DE (MUENCHEN) coordinator 1˙641˙600.00
2    ORION CLINICAL SERVICES LTD UK (SLOUGH) participant 2˙099˙005.00
3    CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE NANCY FR (NANCY CEDEX) participant 507˙570.00
4    OSPEDALE PEDIATRICO BAMBINO GESU IT (ROMA) participant 442˙025.00
5    Universitair Ziekenhuis Gent BE (Gent) participant 401˙550.00
6    ACADEMISCH ZIEKENHUIS LEIDEN NL (LEIDEN) participant 350˙600.00
7    UNIVERSITY OF NEWCASTLE UPON TYNE UK (NEWCASTLE UPON TYNE) participant 349˙725.00
8    MILTENYI BIOTEC GMBH DE (BERGISH GLADBACH) participant 207˙925.00

Map

 Project objective

Allogeneic stem cell transplantation (HSCT) is a curative treatment for a variety of diseases. Viral infections such as Cytomegalovirus (CMV), Epstein-Barr-virus (EBV) and Adenovirus (AdV) are major unsolved problems for patients receiving allogeneic HSCT. Refractory viral infections post-HSCT are rare, life-threatening conditions due to the deficient T-cell response post-SCT and lacking effective treatment options. Protective T-cell immunity could be restored by means of a procedure known as adoptive T-cell transfer. Although cellular immunotherapy is considered a major recent breakthrough in medicine, none of the cellular treatment approaches has yet become a standard treatment. The reason for this limited translation into daily clinical practice is the lack of controlled, prospective clinical trials investigating efficacy of immunotherapy. The objective of TRACE is to bring adoptive T-cell transfer into clinical routine as a life-saving, curative and safe treatment for refractory viral infection post-HSCT. TRACE is a multi-national clinical trial to prove efficacy and safety of adoptive T-cell transfer in immune-compromized individuals. For the first time, this trial will show that a unique individualized immunotherapy could be included into evidence based clinical routine in rare diseases. Regulatory and structural hurdles will be overcome by standardized GMP-procedures. It will be a major milestone in the development of medicine and health economics to bring such a unique personalized treatment approach into a clinical efficacy trial. The consortium provide excellence in immunotherapy through partners from basic, clinical and industrial research and GMP facilities, with proven qualification and expertise in the field of HSCT, GMP manufacturing and adoptive T-cell transfer. It will bring medicine towards physiological self-protection of the human body instead of cost-intensive toxic agents and will thereby improve survival and quality of life.

 Deliverables

List of deliverables.
Individualized press release for every partner Documents, reports 2020-04-07 22:49:03
Registration number of clinical study in a WHO- or ICMJE-approved registry Documents, reports 2020-04-07 22:49:03
Final version of study protocol as approved by first regulatory/ethics committee (Package 1) Documents, reports 2020-04-07 22:49:03
Launch of website and social media account Websites, patent fillings, videos etc. 2020-04-07 22:49:03
Plan for the analysis of the functional activity of the multivirus-specific T cell product Documents, reports 2020-04-07 22:49:03
SOP for immune monitoring of patient samples Documents, reports 2020-04-07 22:49:03
Site selection Documents, reports 2020-04-07 22:49:03

Take a look to the deliverables list in detail:  detailed list of TRACE deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Theresa Kaeuferle, Ramona Krauss, Franziska Blaeschke, Semjon Willier, Tobias Feuchtinger
Strategies of adoptive T -cell transfer to treat refractory viral infections post allogeneic stem cell transplantation
published pages: 12-13, ISSN: 1756-8722, DOI: 10.1186/s13045-019-0701-1
Journal of Hematology & Oncology 12/1 2020-04-07

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The information about "TRACE" are provided by the European Opendata Portal: CORDIS opendata.

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