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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.
ClinicalTrials.gov Identifier:
NCT00823316
First received: January 13, 2009
Last updated: April 20, 2012
Last verified: April 2012

January 13, 2009
April 20, 2012
August 2008
February 2010   (final data collection date for primary outcome measure)
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate [ Time Frame: 28 and 100 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00823316 on ClinicalTrials.gov Archive Site
- AGVHD grade [ Time Frame: 100 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Leukemia
  • Biological: Human umbilical cord blood-derived mesenchymal stem cells
    1x1,000,000 hMSC/kg, IV after unrelated HSCT
    Other Name: PROMOSTEM
  • Biological: Human umbilical cord blood-derived mesenchymal stem cells
    5x1,000,000 hMSC/kg, IV after unrelated HSCT
    Other Name: PROMOSTEM
  • Experimental: 1
    at a dose of 1x1,000,000 hMSC/kg
    Intervention: Biological: Human umbilical cord blood-derived mesenchymal stem cells
  • Experimental: 2
    at a dose of 5x1,000,000 hMSC/kg
    Intervention: Biological: Human umbilical cord blood-derived mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
2 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00823316
MP-CR-MSC003
Yes
Medipost Co Ltd.
Medipost Co Ltd.
Not Provided
Principal Investigator: Hong Hoe Koo, MD, PhD Samsung Medical Center
Medipost Co Ltd.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP