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The Safety of Human Cord Blood-derived Mesenchymal Stem Cells Therapy in Patients with Peripheral Arterial Occlusive Disease:Phase 1 Clinical Study

Status Approved

  • First Submitted Date

    2011/08/03

  • Registered Date

    2011/10/05

  • Last Updated Date

    2011/10/05

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
    KCT0000194
    Unique Protocol ID SMC 2010-08-054-002
    Public/Brief Title The Study of Human Cord Blood-derived Mesenchymal Stem Cells Therapy in Ischemic Limb Disease
    Scientific Title The Safety of Human Cord Blood-derived Mesenchymal Stem Cells Therapy in Patients with Peripheral Arterial Occlusive Disease:Phase 1 Clinical Study
    Acronym
    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 2010-08-054-002
    Approval Date 2010-11-25
    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 Dong-Ik Kim
    Title proffessor
    Telephone +82-2-3410-3467
    Affiliation Samsung Medical Center
    Address
    Contact Person for Public Queries
    Name Dong-Ik Kim
    Title proffessor
    Telephone +82-2-3410-3467
    Affiliation Samsung Medical Center
    Address
    Contact Person for Updating Information
    Name Kyounghwan Roh
    Title
    Telephone +82-2-880-1298
    Affiliation Seoul National University
    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 2011-05-31 Actual
    Target Number of Participant 10
    Primary Completion Date 2012-04-30 , Anticipated
    Study Completion Date 2012-07-30
    Recruitment Status by Participating Study Site 1
    Name of Study Samsung Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2011-05-31 ,
  • 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 Adult Stem Cell Research Center
    Organization Type Others
    Project ID ASCRC-RA-001
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Adult Stem Cell Research Center
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The Safety of allogenic umbilical cord blood-derived mesenchymal stem cells therapy in patient with peripheral arterial occlusive disease: Phase I Clinical study. 
  • 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
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type /Biological/Vaccine  
    Intervention Description
    - Dose : 1x10^7 cells/injection
    - Injection Route : inject to 20 different sites arround tibial artery and fibular artery which situated below the knee joint of ischemic limb
    - Injection : 1 times  
    Number of Arms 1
    Arm 1

    Arm Label

    Allogenic Umbilical Cord Blood-derived Mesenchymal Stem Cells Injection Group

    Target Number of Participant

    10

    Arm Type

    Experimental

    Arm Description

    In patient with Peripheral Arterial Occlusive Disease, we treat 1x10^7 human Umbilical Cord Blood-derived Mesenchymal Stem Cells one times. Injection Route is ischemic limb area below knee joint, and we inject by intramuscle(IM).
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I74.3)Embolism and thrombosis of arteries of lower extremities 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~80Year

    Description

    1) Among the patients who has Peripheral arterial occlusive disease caused by Buerger's disease and arteriosclerosis and at the same time their ABI (resting ankle-brachial index) is lower than 0.9 follow by hemodynamical definition.
    
    (1) Rutherford’s (Fontaine’s stages IIb, III, IV) 3, 4, 5, and 6 (reference 12) patient who has at least 3months claudification or pain during a rest or gangrene or ulcer with irrespective period.
    (but, patient who does not get better with medication and improvement of life style during 3months will be a candidate for Category 3)
    (2) patient who is Inapplicable by Bypass surgery or percutaneous transluminal angioplasty;    
    
    In case of patients with bypass surgery or percutaneous transluminal angioplasty cannot be applied; By doctors from Vascular surgery, cardiovascular medicine, and department of radiology determines bypass surgy and percutaneous transluminal angioplasty is not applicable through reffering system. 
    2) Person who agree to the agreement by themselves by fully explained about purpose, content and  charateristic of trial medicine before participate
    
    Exclusion Criteria
    (1) Under 18
    (2) Medical history of allergy or anaphylatic shock
    (3) Medical history of Autoimmune disease 
        (rheumatoid arthritis, systemic lupus erythematosus, ....)or Hypercoagulated disease
    (4) Having the bypass surgery or angioplasty of artery or aorta within first 
        two months of visit
    (5) Medical history of being treated with other cell therapy of gene therapy
    (6) Having a Heart failure of NYHA functional classification III & IV (reference 13)
    (7) Having unstable angina
    (8) Medical history of acute ST-segment elevation with myocardial infarction within 
        a first month of visit
    (9) Medical history of transient ischemic attack or stroke within a first month of visit
    (10) Severe valvular heart disease
    (11) Uncontrolled diabetes (HbA1c > 8%)
    (12) Renal failure (creatinine > 2.5)
    (13) Medical history of having malignant tumor or being treated with radiation therapy or chemotherapy within five years
    (14) Pregnant or lactating or possible pregnancy women who is free to medically  
         accepted method of birth control  
    (15) Having cognitive dysfunction and walking disability 
    (16) Having infectious disease
    (17) Severe disease patient who might die during follow-up period because of their 
         one year life expectancy   
    (18) WBC < 4,000 or WBC > 15,000
    (19) AST (GOT) > 100 or ALT (GPT) > 100
    (20) Having gait disturbance  by neurology cause
    (21) Disqualified as a suitable subjest by tester
    (22) Uncontrolled hypertension 
    (23) Currently receiving immunosuppressive therapy or chemical therapy
    (24) Hematodyscrasia patient with hemorragic diathresis   
    (25) Participated in other clinical trials
    (26) Patient with Hb<10 and thrombocyte<100,000 
    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
    Primary Outcome(s) 1
    Outcome
    Adverse Effect
    Timepoint
    During treatment period
    Secondary Outcome(s) 1
    Outcome
    Scale for gauging changes in clinical status
    Timepoint
    During treatment period
  • 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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