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
About this trial
This is an interventional treatment trial for Central Nervous System Injury
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
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
NCT ID
NCT03291366
First Posted
September 20, 2017
Last Updated
September 20, 2017
Sponsor
Fuzhou General Hospital
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
Learn more about this trial
Mesenchymal Stem Cells in Central Nervous System injury2017
We'll reach out to this number within 24 hrs