Trial | NCT00823316  Report issue

Title

Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
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.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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.
Study Started
Aug 31
2008
Primary Completion
Feb 28
2010
Study Completion
Feb 28
2010
Last Update
Apr 23
2012
Estimate

Biological Human umbilical cord blood-derived mesenchymal stem cells

1x1,000,000 hMSC/kg, IV after unrelated HSCT

  • Other names: PROMOSTEM

Biological Human umbilical cord blood-derived mesenchymal stem cells

5x1,000,000 hMSC/kg, IV after unrelated HSCT

  • Other names: PROMOSTEM

1 Experimental

at a dose of 1x1,000,000 hMSC/kg

2 Experimental

at a dose of 5x1,000,000 hMSC/kg

Criteria 

Inclusion Criteria:

Patient age 2~19 years old with plan to have unrelated hematopoietic stem cell transplantation with acute leukemia
Patient never has an experience of hematopoietic stem cell transplantation
Patient must have an acute leukemia with a complete remission.
Patients must have an ECOG 0~2.
No moderate or sever organ dysfunction : Ejection fraction > 45%; Creatinine <2.0 mg/ml; Serum bilirubin < 2 mg/ml; AST/ALT < 200 IU/L.
Patient must not have an transplantation with different source of hematopoietic stem cell such as bone marrow and cord blood.
Patient must not have an infection needed an administration of non-oral antibiotics.
No active severe infection derived form virus or fungus.
Each patient / patient's guardian must sign written informed consent.

Exclusion Criteria:

Patient has previously received hematopoietic stem cell transplantation.
Patient plans to have a related hematopoietic stem cell transplantation.
Patient has a severe internal disease.
Patient has enrolled another clinical trial study within last 4 weeks.
No Results Posted