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

Study Overview
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Brief Summary
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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

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Procedure: Autologous Adipose Tissue derived MSCs Transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Adipose Tissue derived MSCs<br> | Procedure: Autologous Adipose Tissue derived MSCs Transplantation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 32 weeks | 
| MEP/SSEP | To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs. | 32 weeks | 
| 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. | 32 weeks | 
| SF-36 | To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs. | 32 weeks | 
| 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. | 32 weeks | 
| Frequency of Adverse Events |  | 32 weeks |