Acute Leukemia Clinical Trial
Official title:
Phase 1/2 Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells Infusion for Promotion of Engraftment and Prevention of an Graft Rejection and Graft-versus-Host Disease After Unrelated Hematopoietic Stem Cell Transplantation.
The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.
- Hematopoietic stem cell transplantation (HSCT) is a procedure in which progenitor cells
capable of reconstituting normal bone marrow function are administered to a patient.
This procedure has been used to treat adults and children with life-threatening
hematological malignancies and congenital immunodeficiency disorders.
- In HSCT, therapeutic goal is an elimination of disease and enrichment of regenerating
capacity to achieve engraftments resulting in continued generation of functional blood
elements from the engrafted living cells. Transplantation of unrelated hematopoietic
stem cells originating either from adult bone marrow or from peripheral blood often
leads to graft-versus host-disease (GvHD), opportunistic infections and graft failure
after transplantation.
- In HSCT, MSC have been used as a therapy for GvHD and other complications. The aim of
MSC infusions in HSCT is to use the cells' immunomodulatory effects to promote
engraftment and to reduce the immunological reactions giving rise to GvHD.
- There is a growing interest in co-transplantation of MSC and HSC to improve the donor
outcome in the unrelated HSCT condition.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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