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Mesenchymal Stem Cells for Steroid-Resistant aGVHD
NCT02770430Phase 2
Key facts
- Status
- Unknown
- Start
- Sep 2015
- Primary completion
- Sep 2017
- Countries
- 1
- Sponsor
- Hospital de Clínicas de Porto Alegre
- Modality
- Stem Cell Therapies
- Conditions
- Acute Graft-Versus-Host Disease (aGvHD)
01
Overview
Phase 2, randomised, open-label trial of mesenchymal stem cells in Acute Graft-Versus-Host Disease (aGvHD) (2 arms), sponsored by Hospital de Clínicas de Porto Alegre. Primary endpoint: Complete Response at 28 days. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
mesenchymal stem cells
MSC infusions
conventional treatment
Basiliximab and/or Infliximab
03
Who it enrols
Patients with steroid-refractory or resistant acute GVHD (Grade II-IV).
04
Endpoints
Primary
Complete Response
Secondary
Partial Response
Very Good Partial Response
Stable Disease
Number of Infections
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