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

Not Applicable

• Conditions: Bone Nonunion
• Interventions: Biological: Umbilical cord blood mononuclear cells; Drug: Staphylococcal Enterotoxin C

• Registration Number: NCT04997590
• Lead Sponsor: Qianfoshan Hospital

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.

Study Timeline

• Study Start: 2020-12-10
• Study First Submitted: 2021-07-26
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-02
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-09
• Primary Completion: 2021-12-10
• Study Completion: 2022-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical cord blood mononuclear cells group	Umbilical cord blood mononuclear cells	Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total.
Staphylococcal Enterotoxin C group	Staphylococcal Enterotoxin C	Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total.

Primary Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

China, Shandong Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China