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Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in 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 MSCs Transplantation
Sponsored by
R-Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who understand and sign the consent form for this study
  • Age : 19-70
  • Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C)
  • Duration of injury : > 3 month

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 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
  • 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

  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Adipose Tissue derived MSCs

Arm Description

Outcomes

Primary Outcome Measures

ASIA (American Spinal Injury Association) scale
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.

Secondary Outcome Measures

Magnetic Resonance Imaging
To evaluate the change of treated spinal cord injury using Magnetic Resonance Imaging (MRI) at 3 and 6 months post injection of MSCs.
MEP/SSEP
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
ADL (activities of daily living)
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
SF-36
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
ODI (Oswestry Disability Questionnaire)
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Frequency of Adverse Events

Full Information

First Posted
January 15, 2013
Last Updated
August 1, 2016
Sponsor
R-Bio
Collaborators
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01769872
Brief Title
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
Official Title
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
Collaborators
Korea University Anam Hospital

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury

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, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Adipose Tissue derived MSCs
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Autologous Adipose Tissue derived MSCs Transplantation
Intervention Description
Intravenous injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e8 cells / 20mL Intrathecal injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 5x10e7 cells / 2mL Into a spinal cord injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e7 cells / 1mL
Primary Outcome Measure Information:
Title
ASIA (American Spinal Injury Association) scale
Description
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Magnetic Resonance Imaging
Description
To evaluate the change of treated spinal cord injury using Magnetic Resonance Imaging (MRI) at 3 and 6 months post injection of MSCs.
Time Frame
32 weeks
Title
MEP/SSEP
Description
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Time Frame
32 weeks
Title
ADL (activities of daily living)
Description
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Time Frame
32 weeks
Title
SF-36
Description
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Time Frame
32 weeks
Title
ODI (Oswestry Disability Questionnaire)
Description
To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Time Frame
32 weeks
Title
Frequency of Adverse Events
Time Frame
32 weeks

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: Subjects who understand and sign the consent form for this study Age : 19-70 Clinical diagnosis of spinal cord injury(American Spinal Injury Association[ASIA] Impairment Scale[AIS] grade A or B or C) Duration of injury : > 3 month 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 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 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
Tai-Hyoung Cho, M.D. & Ph.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury

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