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.
2 Years
19 Years
Both
Acute Leukemia
Trial Information
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
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.
Inclusion Criteria:
1. Patient age 2~19 years old with plan to have unrelated hematopoietic stem cell
transplantation with acute leukemia
2. Patient never has an experience of hematopoietic stem cell transplantation
3. Patient must have an acute leukemia with a complete remission.
4. Patients must have an ECOG 0~2.
5. No moderate or sever organ dysfunction : Ejection fraction > 45%; Creatinine <2.0
mg/ml; Serum bilirubin < 2 mg/ml; AST/ALT < 200 IU/L.
6. Patient must not have an transplantation with different source of hematopoietic stem
cell such as bone marrow and cord blood.
7. Patient must not have an infection needed an administration of non-oral antibiotics.
8. No active severe infection derived form virus or fungus.
9. Each patient / patient's guardian must sign written informed consent.
Exclusion Criteria:
1. Patient has previously received hematopoietic stem cell transplantation.
2. Patient plans to have a related hematopoietic stem cell transplantation.
3. Patient has a severe internal disease.
4. Patient has enrolled another clinical trial study within last 4 weeks.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate
Outcome Time Frame:
28 and 100 days
Safety Issue:
No
Principal Investigator
Hong Hoe Koo, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Samsung Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
MP-CR-MSC003
NCT ID:
NCT00823316
Start Date:
August 2008
Completion Date:
February 2010
Related Keywords:
- Acute Leukemia
- Mesenchymal Stem Cells
- Allogeneic Transplantation
- Engraftment
- GvHD
- Childhood
- unrelated HSCT
- Leukemia
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