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Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury. (MSC)

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Autologous Adipose Derived Mesenchymal Stem Cells
Sponsored by
R-Bio
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

19 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who understand and sign the consent form for this study.
  • Age :19-60, males
  • Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)
  • Duration of injury : > 2 months

Exclusion Criteria:

  • Subjects who must put on a respirator
  • Subjects who had malignant tumor within 5 years
  • Subjects with a infectious disease include HIV and hepatitis
  • Subjects who injured brain or spinal cord before spinal cord injury
  • Subjects who has high body temperature more than 38℃ or acute disorder
  • Subjects with anemia or thrombocytopenia
  • Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
  • Subjects with congenital or acquired immunodeficiency disorders
  • Subjects with muscular dystrophy or articular rigidity
  • Patients with clouded consciousness or speech disorder
  • treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
  • participating another clinical trials within 3 months
  • other serious disease or disorder that could seriously affect ability to participate in the study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    safety evaluation
    Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected

    Secondary Outcome Measures

    Full Information

    First Posted
    January 6, 2011
    Last Updated
    March 24, 2014
    Sponsor
    R-Bio
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01274975
    Brief Title
    Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.
    Acronym
    MSC
    Official Title
    Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    R-Bio

    4. Oversight

    5. Study Description

    Brief Summary
    This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.
    Detailed Description
    Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy. With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to cell-damaged diseases have increased. In a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hAdMSCs (4×10e8 cells) one time.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Autologous Adipose Derived Mesenchymal Stem Cells
    Other Intervention Name(s)
    Astrostem®
    Intervention Description
    Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells
    Primary Outcome Measure Information:
    Title
    safety evaluation
    Description
    Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected
    Time Frame
    12weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects who understand and sign the consent form for this study. Age :19-60, males Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C) Duration of injury : > 2 months Exclusion Criteria: Subjects who must put on a respirator Subjects who had malignant tumor within 5 years Subjects with a infectious disease include HIV and hepatitis Subjects who injured brain or spinal cord before spinal cord injury Subjects who has high body temperature more than 38℃ or acute disorder Subjects with anemia or thrombocytopenia Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease Subjects with congenital or acquired immunodeficiency disorders Subjects with muscular dystrophy or articular rigidity Patients with clouded consciousness or speech disorder treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials participating another clinical trials within 3 months other serious disease or disorder that could seriously affect ability to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SangHan Kim, MD
    Organizational Affiliation
    Anyang Sam Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21303266
    Citation
    Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
    Results Reference
    result

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    Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.

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