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Umbilical cord blood-derived mesenchymal stem cells for the treatment of steroid-refractory acute or chronic graft-versus-host-disease

Status Approved

  • First Submitted Date

    2012/02/07

  • Registered Date

    2012/03/27

  • Last Updated Date

    2012/03/23

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    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
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    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
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Hong Hoe Koo
    Title MD, PhD
    Telephone +82-2-3410-3524
    Affiliation Samsung Medical Center
    Address
    Contact Person for Public Queries
    Name Meong Hi Son
    Title MD, Fellow
    Telephone +82-2-3410-0870
    Affiliation Samsung Medical Center
    Address
    Contact Person for Updating Information
    Name Na Kyoung Ahn
    Title Associate Manager
    Telephone +82-2-3465-6744
    Affiliation Medipost
    Address
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    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 Samsung Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2012-01-05 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Medipost
    Organization Type Pharmaceutical Company
    Project ID MP-CR-008
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Samsung Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    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 1
    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. 
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (T86.0)Bone-marrow transplant rejection 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    0Year~30Year

    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
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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