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Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. The investigators will infuse expanded autologous MSCs and BMMNCs into patients with osteonecrosis of the femoral head. The study purpose is to examine whether this treatment will result in improvement in osteonecrosis of the femoral head.
Mesenchymal Stem Cells (MSCs) have been shown to have immunosuppressive and repairing properties. Bone marrow mononuclear cells (BMMNCs) have revascularization properties and complimentary effects to MSCs. Patients in this study will receive infusion of expanded autologous MSC and BMMNCs. The puncture of femoral artery will be conducted with digital subtraction angiography(DSA), and the tubes will be inserted into medial femoral circumflex artery,lateral femoral circumflex artery and obturatou artey. The study will evaluate the safety and effectiveness of MSC infusion in patients with osteonecrosis of the femoral head. This study will last for 5 years. Patients will undergo infusions at Day 0. Afterward, patients will be evaluated for response, and undergo X-ray examination, CT and MR scanning at a 6-month interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stem cell | Experimental | mesenchymal stem cell infusion and bone marrow mononuclear cell infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cell infusion | Biological |
|
| |
| bone marrow mononuclear cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The femoral head blood-supply artery angiographies and the areas of femoral head necrosis | 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Coxa joint paining | 2 | |
| Walking distance | 2 | |
| Joint functions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianming Tan, professor | Fuzhou General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou General Hospital | Fuzhou | Fujian | 350025 | China |
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| ID | Term |
|---|---|
| D007873 | Legg-Calve-Perthes Disease |
| ID | Term |
|---|---|
| D005271 | Femur Head Necrosis |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Biological |
|
|
| 2 |
| Life | 2 |