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

Bone Nonunion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997590
• Other study ID #: YXLL-KY-2020(041)
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: December 10, 2022

Study information

• Verified date: August 2021
• Source: Qianfoshan Hospital
• Contact: Chunming Zhang, doctor
• Phone: +8618663761275
• Email: liangjing0531[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Nonunion
• Fractures, Bone

Intervention

Biological:
• Umbilical 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.

Drug:
• Staphylococcal Enterotoxin C
injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.

Locations

Country	Name	City	State
China	China, Shandong Qianfoshan Hospital	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qianfoshan Hospital	Shandong Qilu Stem Cells Engineering Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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