RETHRIM is a research consortium sponsored by the European Union’s Horizon 2020 research and innovation programme. The consortium is coordinated by Prof. WE Fibbe from the Leiden University Medical Centre (LUMC) and started in January 2015 with a budget of 5.9 million Euros over 5 years. The consortium had its kick-off meeting on March 2-3, 2015 in the Leiden Observatory in the Netherlands.
Stem cell regenerative therapies hold great promise for patients suffering from a variety of disorders. Mesenchymal Stromal Cells (MSC) which are currently tested in a large number of clinical trials are promising candidate cells for regenerative therapies. However, their presumed effectiveness is based on small non-controlled phase I/II studies. Results of controlled randomized studies are not available hampering safety and efficacy assessment. The RETHRIM consortium has developed an academic infrastructure for the harmonized production of MSC and assembled clinical experts to conduct the first Europe-wide multi-centre 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 whereas patient samples will be used to develop assays for the prediction of clinical response. Alongside the clinical trial, data from quality of life, health technology assessment and ethical studies will be collected. Output from these studies will allow the consortium to formulate a set of measures to convince health authorities, regulatory bodies and insurance companies on the usefulness of MSC therapy and provide suggestions and recommendations for changes in clinical practise, legislation and regulation of MSC regenerative therapy.
- Coordinator Prof. Dr. Wim Fibbe, Head of the Department of Immunohematology and Blood Transfusion and Director of Division 4, LUMC
- Project Manager, Dr. Brigitte Wieles, Dept. of Immunohematology and Blood Transfusion, LUMC, firstname.lastname@example.org
RETHRIM receives funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 643580 and the clinical trial is sponsored by HOVON.