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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times.
injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.
China, Shandong Qianfoshan Hospital
Jinan, Shandong, China
RECRUITINGBone 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month to 1 year after treatment
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