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

Provider

Ministry of Education, Youth and Sports

Programme

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Call for proposals

7E13020-2013

Main participants

Institut klinické a experimentální medicíny

Contest type

RP - Co-financing of EC programme

Contract ID

MSMT-42111/2013

Project name in Czech

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

Annotation in Czech

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.

R&D category

AP - Applied research

CEP classification - main branch

FJ - Surgery including transplantology

CEP - secondary branch

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CEP - another secondary branch

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OECD FORD - equivalent branches <br>(according to the <a href="http://www.vyzkum.cz/storage/att/E6EF7938F0E854BAE520AC119FB22E8D/Prevodnik_oboru_Frascati.pdf">converter</a>)

30212 - Surgery<br>30213 - Transplantation

Provider evaluation

U - Uspěl podle zadání (s publikovanými či patentovanými výsledky atd.)

Project results evaluation

Following the condition that the candidate of financial contribution was evaluated and afterwards selected by international provider in accordance with the rules of the program the Ministry of Education, Youth ans Sports does not realize the evaluation of project results. The project is evaluated only after its approval by an international provider.

Realization period - beginning

Jan 1, 2013

Realization period - end

Oct 31, 2018

Project status

U - Finished project

Latest support payment

Feb 15, 2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data delivery code

CEP19-MSM-7E-U/01:1

Data delivery date

Jun 18, 2019

Total approved costs

4,270 thou. CZK

Public financial support

4,270 thou. CZK

Other public sources

0 thou. CZK

Non public and foreign sources

0 thou. CZK