Graft Versus Host Disease Clinical Trial
Official title:
Multicenter Clinical Trial Phase I/II Randomized, Controlled, for the Evaluation of Safety and Feasibility of Therapy With Two Different Doses of Allogenic Mesenchymal Stem Cells From Adipose Tissue in Patients With Chronic Graft Versus Host Disease.
The main purpose of this trial is to assess the safety and feasibility of treatment with
two-dose infusion of allogeneic mesenchymal stem cells from adipose tissue expanded in vitro
in patients undergoing haematopoietic stem cell transplantation (HSCT, who have developed
chronic and extensive graft versus host disease (GVHD).
Mesenchymal stem cells (MSCs) express low levels of HLA class I molecules, and do not
express class II molecules neither CD40, CD80 and CD86, being unable to induce proliferation
of allogeneic lymphocytes. In addition, MSCs inhibit lymphocyte proliferation by inhibiting
cell division and maintaining these cells in a quiescent state. This supports the hypothesis
that MSCs are universal suppressors.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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