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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2012/02/07
    • Registered Date : 2012/03/27
    • Last Updated Date : 2012/03/23
Background Information
1.Background  
CRIS Registration Number KCT0000389 
Unique Protocol ID SMC 2011-06-025 
Public/Brief Title Investigator initiated trial to evaluate the safety and efficacy of umbilical cord blood-derived mesenchymal stem cells for treatment of pediatric patients with steroid-refractory acute or chronic graft versus host disease. 
Scientific Title Umbilical cord blood-derived mesenchymal stem cells for the treatment of steroid-refractory acute or chronic graft-versus-host-disease  
Acronym UCB-MSC GVHD 
MFDS Regulated Study Yes
IND/IDE Protocol Yes
Registered at Other Registry No
Healthcare Benefit
Approval Status
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number SMC 2011-06-025  
Approval Date 2011-08-27 
Institutional Review Board  
- Name Samsung Medical Center Institutional Review Board  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Hong Hoe Koo 
- Title MD, PhD 
- Telephone  
- Affiliation Samsung Medical Center  
- Address  
Contact Person for Public Queries
- Name Meong Hi Son 
- Title MD, Fellow 
- Telephone  
- Affiliation Samsung Medical Center  
- Address  
Contact Person for Updating Information
- Name Na Kyoung Ahn 
- Title Associate Manager 
- Telephone  
- Affiliation Medipost 
- Address  
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2012-01-05 , Actual
Target Number of Participant 30
Primary Completion Date 2012-12-31 , Anticipated
Study Completion Date 2012-12-31 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Samsung Medical Center  
- Recruitment Status Recruiting  
- Date of First Enrollment 2012-01-05 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Medipost 
- Organization Type Pharmaceutical Company  
- Project ID MP-CR-008 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Samsung Medical Center  
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary Graft-versus-host-disease(GVHD) is a major complication following allogeneic hematopoietic stem cell transplantation which may cause acute life-threatening morbidity or chronic disabilities. Although corticosteroid, the primary agent to treat GVHD, may be effective for some patients, outcomes of those who are refractory to corticosteroid are dismal. Secondary agents used for steroid-refractory cases in pediatric group is limited. Many in vitro and in vivo data support immunoregulatory properties of mesenchymal stem cells(MSCs)and possibilities of treating diseases caused by immune dysregulation such as GVHD. We designed this study to evaluate the safety and efficacy of UCB-MSCs in treating pediatric patients with steroid-refractory acute or chronic GVHD.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase1/Phase2 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation Not Applicable 
Intervention Type /Biological/Vaccine  
Intervention Description Allogeneic-Unrelated, Umbilical Cord Blood-Derived Mesenchymal stem cells( PROMOSTEM ®). 1st MSC infusion(1x10^6cells/kg)IV, 2nd MSC infusion(2x10^6cells/kg)IV and 3rd MSC infusion(3x10^6cells/kg)IV if no complete response at 28 days.
- Follow-up for 180 days after first infusion.  
Number of Arms
Arm 1 Arm Label PROMOSTEM 
Target Number of Participant 30 
Arm Type Others 
Arm Description Allogeneic-Unrelated, Umbilical Cord Blood-Derived Mesenchymal stem cells( PROMOSTEM ®). 1st MSC infusion(1x10^6cells/kg)IV, 2nd MSC infusion(2x10^6cells/kg)IV and 3rd MSC infusion(3x10^6cells/kg)IV if no complete response at 28 days. - Follow-up for 180 days after first infusion.  
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 0 Year ~ 30 Year
Description 1. Steroid-refractory acute or chronic graft-versus-host-disease
2. Acquisition of consent form
3. 0-30 years of age
 
Exclusion Criteria 1. Withdrawal from the study
2. Progression of underlying hematologic diseases
3. Severe adverse effects related to the investigational drug

 
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
- Outcome Safety(Vital sign, Physical examination, ECOG performance status/Adverse effects related to infusion) 
- Timepoint After 1~2 weeks of infusion/During the infusion 
Primary Outcome(s) 2 
- Outcome Treatment response of GVHD 
- Timepoint Day28, 180 
Secondary Outcome(s) 1 
- Outcome Pediatric Quality of Life inventory 
- Timepoint Day28, 180 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration