Spinal Cord Injury
Conditions
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
Interventions
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
Sponsors
Korea University Anam Hospital
R-Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASIA (American Spinal Injury Association) scale | 32 weeks | To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MEP/SSEP | 32 weeks | 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) | 32 weeks | To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs. |
| Magnetic Resonance Imaging | 32 weeks | To evaluate the change of treated spinal cord injury using Magnetic Resonance Imaging (MRI) at 3 and 6 months post injection of MSCs. |
| ODI (Oswestry Disability Questionnaire) | 32 weeks | 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 | 32 weeks | — |
| SF-36 | 32 weeks | To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs. |
Countries
South Korea
Outcome results
None listed