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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:
ClinicalTrials.gov Identifier:
NCT00823316
First Posted: January 15, 2009
Last Update Posted: April 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medipost Co Ltd.
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • - AGVHD grade [ Time Frame: 100 days ]

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

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Ages Eligible for Study:   2 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT00823316     History of Changes
Other Study ID Numbers: MP-CR-MSC003
First Submitted: January 13, 2009
First Posted: January 15, 2009
Last Update Posted: April 23, 2012
Last Verified: April 2012

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