Graft-vs-Host Disease (GVHD) Clinical Trial
Official title:
A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.
This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10^6
MSC/Kg recipient´s bodyweight).
MSC will be infused, by a central venous catheter, to patients diagnosed with GVHD
refractory to first-line or subsequent treatment.
All patients will receive the same treatment. MSC suspension will be obtained from the bone
marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with
autologous donor´s serum and with no animal-derived products.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment