Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
autologous adipose tissue derived mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring autologous adipose tissue
Eligibility Criteria
Inclusion Criteria:
- Patient who don't have any possiblity of improving neurological function despite performed the optimal treatment after spinal cord injury
- No change in neurological function for 4weeks interval by at least 2 clincal medical specialists
- Patient who is able to give written informed consent of clinical trial about stemcells treatment
Exclusion Criteria:
- Patient who is under 19 years and over 70years
- Patient who must use the mechanical ventilator
- Patient who have a history of malignant tumor within 5 years
- Patient who is having a infectious disease of including current hepatitis and HIV
- Patient who had the brain or spinal cord injury before the spinal cord injury (confirm subject's history from their medical history)
- Patient who is having a acute disease judged by principle investigator or having a fever over 38.0 ℃ at the vaccination day
- Patient who is having an anemia or thrombopenia
- Patient who is having an angina, myocardial infarct, myocardiopathy, obstructive vessel disease, chronic renal failure, glomerulopathy and chronic obstruent lung disease (confirm subject's history from their medical history)
- Patient who is having a Congenital Immune Deficiency Syndrome or AIDS (confirm subject's history from their medical history)
- Patient who is having an amyotrophia or joint atrophy
- Patient who is having an disturbanace of consciousness or dysphrasia
- Patient who is taking an immunosuppressive agents or corticosteroids agents or cytotoxic agents or needed administration
- Patient who have experienced another clinical trials within 3 months involving this clinical trial
- Patient who can't participate in this clinical trial having any opinion regarded as clinical significance judged by principle investigator
Sites / Locations
- Korea University Anam Hospital
Outcomes
Primary Outcome Measures
Significant MRI Change before and after intervention
Secondary Outcome Measures
Significant neurologic funtion Change before and after intervention
Significant Electrophysiological Change before and after intervention
Adverse event
Full Information
NCT ID
NCT01624779
First Posted
June 18, 2012
Last Updated
February 11, 2015
Sponsor
Bukwang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01624779
Brief Title
Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury
Official Title
The Effect of Intrathecal Transplantation of Autologous Adipose Tissue Derived Mesenchymal Stem Cells in the Patients With Spinal Cord Injury, Phase I Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bukwang Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
autologous adipose tissue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
autologous adipose tissue derived mesenchymal stem cells
Intervention Description
autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1&2
Primary Outcome Measure Information:
Title
Significant MRI Change before and after intervention
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Significant neurologic funtion Change before and after intervention
Time Frame
6 month
Title
Significant Electrophysiological Change before and after intervention
Time Frame
6 month
Title
Adverse event
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who don't have any possiblity of improving neurological function despite performed the optimal treatment after spinal cord injury
No change in neurological function for 4weeks interval by at least 2 clincal medical specialists
Patient who is able to give written informed consent of clinical trial about stemcells treatment
Exclusion Criteria:
Patient who is under 19 years and over 70years
Patient who must use the mechanical ventilator
Patient who have a history of malignant tumor within 5 years
Patient who is having a infectious disease of including current hepatitis and HIV
Patient who had the brain or spinal cord injury before the spinal cord injury (confirm subject's history from their medical history)
Patient who is having a acute disease judged by principle investigator or having a fever over 38.0 ℃ at the vaccination day
Patient who is having an anemia or thrombopenia
Patient who is having an angina, myocardial infarct, myocardiopathy, obstructive vessel disease, chronic renal failure, glomerulopathy and chronic obstruent lung disease (confirm subject's history from their medical history)
Patient who is having a Congenital Immune Deficiency Syndrome or AIDS (confirm subject's history from their medical history)
Patient who is having an amyotrophia or joint atrophy
Patient who is having an disturbanace of consciousness or dysphrasia
Patient who is taking an immunosuppressive agents or corticosteroids agents or cytotoxic agents or needed administration
Patient who have experienced another clinical trials within 3 months involving this clinical trial
Patient who can't participate in this clinical trial having any opinion regarded as clinical significance judged by principle investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taehyeong Jo, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seongbukgu
ZIP/Postal Code
136-705
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury
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