RETHRIM is centred around a clinical trial in which patients with Graft versus Host Disease are treated using MSC

 

WP1: project management

The project is coordinated by LUMC.The project management team will coordinate the administrative activities of the project, organize meetings and oversee the overall legal, contractual, ethical, financial and administrative management

WP2: MSC production

The clinical product to be tested in the clinical trial are Mesenchymal Stromal Cells (MSC) In WP2 this product will be produced and the manufacturing of GMP clinical grade MSC according to a standardized protocol will be safeguarded. The products will be analysed for product hetero/homo-geneity.

WP3: Clinical trial 

This WP entails conduct of a prospective, randomized, double-blind, placebo-controlled, multi-centre phase III trial to study the safety, efficacy and repeatability of the use of MSC to repair damaged organs in patients suffering from visceral Graft-versus- Host-Disease (GvHD).

WP4: Biomarker signature

Uses material obtained in the clinical trial to establish the immune reconstitution profile obtained through MSC regenerative therapy. Furthermore,  a laboratory signature associated with the patients' response to MSC therapy will be determined.

WP5: Quality of life

Improvement in Quality of Life in patients treated with MSC will be assessed and compared to the placebo control group.

WP6: Health Technology assessment

The economic and health impact using MSC for the treatment of visceral GvHD will be evaluated. Economic assessment of a treatment is important to convince health insurance companies of the economic impact of a therapy.

WP7: Ethical considerations

This WP will propose criteria for the conditions when it is justified to withhold a potential successful treatment benefit in randomized placebo controlled trials and in particular in a phase III trial to study the safety, efficacy and repeatability of the use of MSC to repair damaged organs in patients suffering from visceral Graft-versus-Host-Disease.

WP8: Communication, Dissemination and Exploitation

Informing relevant stakeholders (science, clinicians, European Policy makers, health authorities, interested commercial partners and the lay public) of the project results is an important aspect to gain support for MSC based therapies in general and to treat GvHD in particular.