- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823316
Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
April 20, 2012 updated by: Medipost Co Ltd.
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
at a dose of 1x1,000,000 hMSC/kg
|
1x1,000,000 hMSC/kg, IV after unrelated HSCT
Other Names:
5x1,000,000 hMSC/kg, IV after unrelated HSCT
Other Names:
|
Experimental: 2
at a dose of 5x1,000,000 hMSC/kg
|
1x1,000,000 hMSC/kg, IV after unrelated HSCT
Other Names:
5x1,000,000 hMSC/kg, IV after unrelated HSCT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate
Time Frame: 28 and 100 days
|
28 and 100 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- AGVHD grade
Time Frame: 100 days
|
100 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hong Hoe Koo, MD, PhD, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 13, 2009
First Submitted That Met QC Criteria
January 14, 2009
First Posted (Estimate)
January 15, 2009
Study Record Updates
Last Update Posted (Estimate)
April 23, 2012
Last Update Submitted That Met QC Criteria
April 20, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MP-CR-MSC003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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