Restoring tissue generation in patients with visceral Graft versus Host Disease

RETHRIM is a European research project “Restoring tissue regeneration in patients with visceral Graft versus Host Disease” funded within the EU Framework Programme for Research and Innovation Horizon 2020 (grant agreement number 643580). The primary objective of the project is to improve the response rate to treatment of acute Graft versus Host Disease (GvHD) grade II-IV (with gut and/or liver involvement) by early addition of Mesenchymal stem cells (MSCs) to standardized second line treatment, whereas developing a score allowing identification of patients with acute GvHD that will respond to MSC treatment is among the secondary objectives. The project involves a prospective, multi-center, placebo-controlled, double-blind phase III trial, including not only adult participants, but also minors. This project devotes considerable attention to ethical questions relevant to conducting of this clinical trial, such as criteria for the use of placebo control when some countries have granted conditional or even full approval of the use of MSCs for the given condition; or identifying the ethical hurdles involved in obtaining Europe-wide ethical approval in the setting of a randomized placebo controlled phase III trials.

RETHRIM is an EU-funded research project within Horizon 2020 Programme, with a primary aim to improve the response rate to treatment of steroid-refractory acute Graft versus Host Disease by adding Mesenchymal stem cells to second line treatment. The project involves a placebo-controlled, double-blind phase III trial, including both adults and children, and pays considerable attention to ethical issues relevant to conducting of this clinical trial.