Status:
COMPLETED
Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Medipost Co Ltd.
Conditions:
Acute Leukemia
Eligibility:
All Genders
2-19 years
Phase:
PHASE1
PHASE2
Brief Summary
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 prom...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00823316
Start Date
August 1 2008
End Date
February 1 2010
Last Update
April 23 2012
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710