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More info
You can access this
clinical trial
if you have
Graft vs Host Disease
and you are
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Biological: mesenchymal stem cells
  • Drug: conventional treatment
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Locations near you

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Tris trial is registered with FDA with number: NCT02770430. The sponsor of the trial is Hospital de Clinicas de Porto Alegre and it is looking for 90 volunteers for the current phase.
Official trial title:
A Phase II, Randomized Study to Evaluate the Human Mesenchymal Stem Cells as a First-line Treatment for aGVHD in Patients Steroids Resistant.