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| Name | Class |
|---|---|
| SMG-SNU Boramae Medical Center | OTHER |
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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 avascular necrosis of the femoral head.
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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 | Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging | To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs. | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SPECT/CT | To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs. | 96 weeks |
| Hip X-ray | To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kang-Sup Yoon, M.D. & Ph.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMG-SNU Boramae Medical Center | Seoul | South Korea |
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| 96 weeks |
| HHS (Harris Hip Score) | To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs. | 96 weeks |
| WOMAC (Western Ontario and McMaster Universities) Index | To evaluate the change of treated femoral head using WOMAC Index at 24 months post injection of MSCs. | 96 weeks |
| UCLA (University of California Los Angeles) hip questionnaire | To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs. | 96 weeks |
| Safety evaluation | 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. | 96 weeks |
| ID | Term |
|---|---|
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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