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Mesenchymal Stem Cells in Central Nervous System injury2017

Primary Purpose

Central Nervous System Injury

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
UCMSCC
conventional treatment
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Nervous System Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CNS injury > 3 months
  • age > 18 years
  • willing to give consent
  • stable vital signs
  • absence of active infectcion

Exclusion Criteria:

  • any contradiction to intrathecal infusion
  • age < 18 years
  • CNS injury < 3 months
  • CNS injury > 3 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MSC

    conventional

    Arm Description

    infusion of aUCMSC and conventional therapy

    conventional therapy

    Outcomes

    Primary Outcome Measures

    life quality score

    Secondary Outcome Measures

    adverse events

    Full Information

    First Posted
    September 20, 2017
    Last Updated
    September 20, 2017
    Sponsor
    Fuzhou General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03291366
    Brief Title
    Mesenchymal Stem Cells in Central Nervous System injury2017
    Official Title
    Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System injury2017
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    January 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fuzhou General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Central nervous system (CNS) injury leads to morbidity in patients, which has few good rehabilitation measures. Mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of MSC in rehabilitate CNS injury.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Nervous System Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MSC
    Arm Type
    Experimental
    Arm Description
    infusion of aUCMSC and conventional therapy
    Arm Title
    conventional
    Arm Type
    Active Comparator
    Arm Description
    conventional therapy
    Intervention Type
    Drug
    Intervention Name(s)
    UCMSCC
    Intervention Description
    infusion of aUCMSC and conventional therapy
    Intervention Type
    Drug
    Intervention Name(s)
    conventional treatment
    Intervention Description
    conventional treatment
    Primary Outcome Measure Information:
    Title
    life quality score
    Time Frame
    1y
    Secondary Outcome Measure Information:
    Title
    adverse events
    Time Frame
    1y

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: CNS injury > 3 months age > 18 years willing to give consent stable vital signs absence of active infectcion Exclusion Criteria: any contradiction to intrathecal infusion age < 18 years CNS injury < 3 months CNS injury > 3 years

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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