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| Name | Class |
|---|---|
| Korea University Anam Hospital | OTHER |
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Adipose Tissue derived MSCs Transplantation | Procedure | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tai-Hyoung Cho, M.D. & Ph.D. | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| 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 |
| D014947 | Wounds and Injuries |