Mesenchymal Stem Cells as First Treatment Line for Resistant Acute Graft Versus Host Disease
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
Steroids are still the first line treatment for established severe
acute-graft-versus-host-disease (aGVHD), with a response rate of 30-50%, and there is no
established and effective therapy for severe steroid-refractory (aGVHD). The outcome for
patients is poor and overall survival low, with few patients alive at 2 years.
In the case of failure after corticosteroid treatment, different therapeutic options have
been introduced as second or third-line strategies. In this scenario, infusion of ex vivo
expanded mesenchymal stromal cells (MSCs) has emerged as an additional tool for treatment of
GVHD.
The purpose of this work is conduct a study in patients with refractory and/or resistant GVHD
corticosteroids treatment. It will be randomized into two groups: one group that will receive
the MSCs and the other group will follow the acute GVHD steroid-resistant and/or refractory
treatment according to the routines of the Bone Marrow Transplantation (BMT) service of
Hospital de Clinicas de Porto Alegre. It will be evaluated aspects of immune recovery early
after MSCs infusion.