CORDIS
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CORDIS

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Restoring tissue regeneration in patients with visceral Graft versus Host Disease.

Objective

Stem cell regenerative therapies hold great promise for patients suffering from a variety of disorders that are associated with tissue or organ injury. Regeneration relies on tissue or organ-specific stem and progenitor cells, but can also aim at promoting the endogenous repair capacity of the body.

Mesenchymal stromal cells (MSC) are undergoing clinical testing in a variety of clinical conditions aiming at repair through direct or indirect mechanisms. Their ability to form bone or cartilage is used to directly repair these tissues. In other conditions their regenerative effects are based on endogenous repair through their anti-inflammatory properties. The latter mechanism is important in the treatment of acute Graft-versus-Host Disease (GvHD). We have been involved in the clinical development from the beginning and we have shown the therapeutic potential. However, no results of controlled randomized phase 3 studies have been published to date, thereby hampering safety and efficacy assessment.

Within our consortium we have developed an academic infrastructure for the harmonized production of MSC. In the RETHRIM proposal this will be combined with our clinical expertise to conduct the first Europe-wide placebo controlled randomized phase III trial using MSC regenerative therapy for the treatment of steroid-resistant visceral GvHD. Central to the RETHRIM project is the clinical trial for which 150 patients will be recruited. All MSC products will be extensively analysed using molecular and functional markers, in order to develop a potency signature for the product and for the prediction of response. We also intend to collect data from additional quality of life, health technology assessment and ethical studies. We will apply for an Orphan Drug Designation in Europe and this may serve as a stepping-stone for the further commercialization of the MSC product, once a positive outcome has been obtained.

Coordinator

ACADEMISCH ZIEKENHUIS LEIDEN

Address

Albinusdreef 2
2333 Za Leiden

Netherlands

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 2 334 931,25

Participants (11)

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KAROLINSKA INSTITUTET

Sweden

EU Contribution

€ 229 912,50

OSPEDALE PEDIATRICO BAMBINO GESU

Italy

EU Contribution

€ 331 537,50

UNIVERSITAET LEIPZIG

Germany

EU Contribution

€ 660 043,75

KATHOLIEKE UNIVERSITEIT LEUVEN

Belgium

EU Contribution

€ 354 850

FUNDACION INSTITUTO DE ESTUDIOS DE CIENCIAS DE LA SALUD DE CASTILLA Y LEON

Spain

EU Contribution

€ 399 787,50

ERASMUS UNIVERSITEIT ROTTERDAM

Netherlands

EU Contribution

€ 309 300

LUNDS UNIVERSITET

Sweden

EU Contribution

€ 333 200

IMMUNOTOOLS GMBH

Germany

EU Contribution

€ 534 025

GENOMIC INVESTMENTS BV

Netherlands

STICHTING HEMATO-ONCOLOGIE VOOR VOLWASSENEN NEDERLAND (HOVON)

Netherlands

GenomeScan B.V.

Netherlands

EU Contribution

€ 370 000

Project information

Grant agreement ID: 643580

Status

Ongoing project

  • Start date

    1 January 2015

  • End date

    31 December 2021

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 857 587,50

  • EU contribution

    € 5 857 587,50

Coordinated by:

ACADEMISCH ZIEKENHUIS LEIDEN

Netherlands