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.
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate
28 and 100 days
Hong Hoe Koo, MD, PhD
Samsung Medical Center
Korea: Food and Drug Administration