Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing
Overview
- Phase
- Not Applicable
- Intervention
- Umbilical cord blood mononuclear cells
- Conditions
- Bone Nonunion
- Sponsor
- Qianfoshan Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Bone defect connection
- Last Updated
- 4 years ago
Overview
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.
Investigators
Lili Cao
Professor
Qianfoshan Hospital
Eligibility Criteria
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.
Arms & Interventions
Umbilical cord blood mononuclear cells group
Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total.
Intervention: Umbilical cord blood mononuclear cells
Staphylococcal Enterotoxin C group
Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total.
Intervention: Staphylococcal Enterotoxin C
Outcomes
Primary Outcomes
Bone defect connection
Time Frame: 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 formation
Time Frame: 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 reconstruction
Time Frame: 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.