Bone Nonunion
Conditions
Keywords
Umbilical cord blood mononuclear cells, Traumatic fracture healing, Bone nonunion
Brief summary
The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.
Detailed description
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.
Interventions
BIOLOGICALUmbilical cord blood mononuclear cells
injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times.
DRUGStaphylococcal Enterotoxin C
injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.
Sponsors
Shandong Qilu Stem Cells Engineering Co., Ltd.
Qianfoshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Traumatic long bone fracture. * Noninfectious bone nonunion, delayed bone union. * 3 months after the operation of the fracture, the examination showed no callus growth, no signs of progressive repair at the fracture site, fracture piece space \< 5mm. * No shortening, angulation and displacement. * There was no obvious callus growth 8 months after local bone grafting.
Exclusion criteria
* There are infection foci at and near the fracture end after fracture. * 3 months after the fracture, tests showed partial callus growth. * Combining shortening, angulation and displacement phenomena. * Partial callus grew 8 months after local bone grafting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone formation | 1 month to 1 year after treatment | 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. |
| Bone defect connection | 1 month to 1 year after treatment | 0 points for complete fracture lines, 2 points for partial fracture lines, 4 points for lack of fracture lines. |
| Bone reconstruction | 1 month to 1 year after treatment | 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. |
Countries
China
Contacts
Primary ContactChunming Zhang, doctor
Outcome results
None listed