REgeneration THRough Immune Modulation.
Phase III clinical trial aiming to establish the standard of treatment for patients with visceral Graft versus Host Disease (GvHD) using mesenchymal stem cell (MSCs)-based regenerative therapy.
H2020-PHC-2014 – Grant Agreement ID 643580
1 January 2015 to 31 December 2021
Allogeneic Stem Cell Transplantation (SCT), where patients receive blood-forming stem cells from a genetically similar – but not identical – donor, represents the only potentially curative form of treatment for many hematological malignant disorders. Depending on the risk factors present, 10-80% of SCT-treated patients develop an immune response initiated from the transplanted stem cells (the graft) towards the patient’s own tissues (the host) called graft-versus-host disease (GvHD). Immuno-suppressive therapy with corticosteroids is effective in 50% of the patients with GvHD, while the other 50% develop steroid refractory GvHD that is associated with a mortality rate of 75%. Stem cell regenerative therapies hold great promise for patients suffering from a variety of disorders that are associated with tissue or organ injury like GvHD. 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 stem cells (MSCs) are undergoing clinical testing in a variety of clinical conditions aiming at repair through direct or indirect mechanisms. Regenerative effects of MSCs in GvHD are based on endogenous repair through their anti-inflammatory properties. The RETHRIM project aims to evaluate the therapeutic anti-inflammatory potential of MSC in the first Europe-wide placebo controlled randomized phase III trial for treatment of steroid-resistant visceral GvHD using MSC regenerative therapy. As one of the beneficiaries, GenomeScan provides Next Generation Sequencing (NGS) services aiming to evaluate the production, validation, and analysis of clinical grade MSC, and contribute to immuno-monitoring & biomarker signature development.
T.b.a. (ongoing project)
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 643580.