Not provided
Not provided
Not provided
Not provided
Not provided
No longer willing to continue clinical trials
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Korea University Anam Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 lumbar intervertebral disc degeneration.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdMSC | Experimental | Autologous Adipose Tissue derived Mesenchymal Stem Cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Adipose Tissue derived MSCs Transplantation | Procedure | Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging | To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Neurological Functions | To evaluate the change of treated lumbar intervertebral discs using Muscle Test, Somatosensory Test, Deep Tendon Reflex and VAS (Visual Analogue Scale Score 0-10) at 6 months post injection of MSCs. | 24 weeks |
| Safety evaluation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests. |
| 24 weeks |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided