Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing

Conditions
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Bone Nonunion

Intervention / Treatment
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* Biological: Umbilical cord blood mononuclear cells
* Drug: Staphylococcal Enterotoxin C


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical cord blood mononuclear cells group<br>Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total. | Biological: Umbilical cord blood mononuclear cells<br>* injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times.<br>|
| Active Comparator: Staphylococcal Enterotoxin C group<br>Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total. | Drug: Staphylococcal Enterotoxin C<br>* injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone nonunion, Umbilical cord blood mononuclear cells, Traumatic fracture healing