Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation
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ClinicalTrials.gov Identifier: NCT00823316 |
Recruitment Status
:
Completed
First Posted
: January 15, 2009
Last Update Posted
: April 23, 2012
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Sponsor:
Medipost Co Ltd.
Information provided by (Responsible Party):
Medipost Co Ltd.
Tracking Information | ||||
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First Submitted Date ICMJE | January 13, 2009 | |||
First Posted Date ICMJE | January 15, 2009 | |||
Last Update Posted Date | April 23, 2012 | |||
Study Start Date ICMJE | August 2008 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
- Day of neutrophil engraftment - Day of platelet engraftment - Evaluation of chimerism - Evaluation of engraftment rate [ Time Frame: 28 and 100 days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00823316 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
- AGVHD grade [ Time Frame: 100 days ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation | |||
Official Title ICMJE | 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. | |||
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 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. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Acute Leukemia | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | February 2010 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 2 Years to 19 Years (Child, Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00823316 | |||
Other Study ID Numbers ICMJE | MP-CR-MSC003 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Medipost Co Ltd. | |||
Study Sponsor ICMJE | Medipost Co Ltd. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medipost Co Ltd. | |||
Verification Date | April 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |