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| Name | Class |
|---|---|
| Shandong Qilu Stem Cells Engineering Co., Ltd. | INDUSTRY |
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The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.
Umbilical cord blood mononuclear cells are a type of cell group containing hematopoietic stem cells, mesenchymal stem cells, neural stem cells, endothelial cells, immune cells, etc.In this study ,umbilical cord blood mononuclear cells will be used in promoting traumatic fracture healing,and the effectiveness and safety of the treatment plan was evaluated by twelve months of follow-up after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical cord blood mononuclear cells group | Experimental | Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total. |
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| Staphylococcal Enterotoxin C group | Active Comparator | Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord blood mononuclear cells | Biological | injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times. |
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| Measure | Description | Time Frame |
|---|---|---|
| Bone formation | If there is no bone formation, 0 points. Bone formation accounts for 25% of the fracture area, 1 point. Bone formation accounts for 50% of the fracture area, 2 points. Bone formation accounts for 75% of the fracture area, 3 points. Bone filled the gap between fracture ends, 4 points. | 1 month to 1 year after treatment |
| Bone defect connection | 0 points for complete fracture lines, 2 points for partial fracture lines, 4 points for lack of fracture lines. | 1 month to 1 year after treatment |
| Bone reconstruction | 0 points for no manifestations of reconstruction,2 points for intramedullary cavity can be reconstructed , and 4 points for the cortical bone can be completely reconstructed. A total score of 11 points or more achieves a good healing effect. | 1 month to 1 year after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunming Zhang, doctor | Contact | +8618663761275 | liangjing0531@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Liang, doctor | Qianfoshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China, Shandong Qianfoshan Hospital | Recruiting | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| C034959 | enterotoxin C, staphylococcal |
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| Staphylococcal Enterotoxin C | Drug | injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times. |
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