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The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.
This is a randomized,double-blind, paralleled study. Patients will be divided into two groups of experiment and control. All of them will receive core decompression of the femoral head, while experimental group patient will transplant hUC-MSC in addition. Follow-up visit will occur on 1 month, 3 months, and 6 months after operation, and Harris Hip score was applied to evaluate the symptoms change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#). |
|
| Group 2 | Placebo Comparator | Core decompression surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) | Drug | Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2*10^7 cells, |
| Measure | Description | Time Frame |
|---|---|---|
| MRI imageological examination | MRI imageological examination to evaluate the efficient of mesenchymal stem cells. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | Evaluate curative effects by the change of Harris hip score. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bahushan | Inner Mongolia International Mongolian Hospital | Study Director |
| Lei Guo, Dr. | China-Japan Union Hospital, Jilin University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inner Mongolia International Mongolian Hospital | Hohhot | Inner Mongolia | 010065 | China |
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| core decompression | Procedure | The surgery will drill into the femoral neck (hip bone) and through the necrotic area of the bone that died from the lack of blood flow, take out partial osseous tissue. |
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| 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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