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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Leukemia
 Biological: Human umbilical cord blood-derived mesenchymal stem cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
  • - 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 ]

Secondary Outcome Measures:
  • - AGVHD grade [ Time Frame: 100 days ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
at a dose of 1x1,000,000 hMSC/kg
 Biological: Human umbilical cord blood-derived mesenchymal stem cells
1x1,000,000 hMSC/kg, IV after unrelated HSCT
Other Name: PROMOSTEM
Experimental: 2
at a dose of 5x1,000,000 hMSC/kg
 Biological: Human umbilical cord blood-derived mesenchymal stem cells
5x1,000,000 hMSC/kg, IV after unrelated HSCT
Other Name: PROMOSTEM

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   2 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823316

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
Principal Investigator: Hong Hoe Koo, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT00823316     History of Changes
Other Study ID Numbers: MP-CR-MSC003
Study First Received: January 13, 2009
Last Updated: April 20, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Medipost Co Ltd.:
Mesenchymal Stem Cells
Allogeneic Transplantation
Engraftment
 GvHD
Childhood
unrelated HSCT

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013