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

Primary Purpose

Bone Nonunion

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Umbilical cord blood mononuclear cells
Staphylococcal Enterotoxin C
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Nonunion focused on measuring Umbilical cord blood mononuclear cells, Traumatic fracture healing, Bone nonunion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China, Shandong Qianfoshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Umbilical cord blood mononuclear cells group

Staphylococcal Enterotoxin C group

Arm Description

Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total.

Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total.

Outcomes

Primary Outcome Measures

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.
Bone defect connection
0 points for complete fracture lines, 2 points for partial fracture lines, 4 points for lack of fracture lines.
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.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2021
Last Updated
August 2, 2021
Sponsor
Qianfoshan Hospital
Collaborators
Shandong Qilu Stem Cells Engineering Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04997590
Brief Title
Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing
Official Title
Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital
Collaborators
Shandong Qilu Stem Cells Engineering Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Nonunion
Keywords
Umbilical cord blood mononuclear cells, Traumatic fracture healing, Bone nonunion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Umbilical cord blood mononuclear cells group
Arm Type
Experimental
Arm Description
Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total.
Arm Title
Staphylococcal Enterotoxin C group
Arm Type
Active Comparator
Arm Description
Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total.
Intervention Type
Biological
Intervention Name(s)
Umbilical cord blood mononuclear cells
Intervention Description
injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times.
Intervention Type
Drug
Intervention Name(s)
Staphylococcal Enterotoxin C
Intervention Description
injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.
Primary Outcome Measure Information:
Title
Bone formation
Description
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.
Time Frame
1 month to 1 year after treatment
Title
Bone defect connection
Description
0 points for complete fracture lines, 2 points for partial fracture lines, 4 points for lack of fracture lines.
Time Frame
1 month to 1 year after treatment
Title
Bone reconstruction
Description
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.
Time Frame
1 month to 1 year after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunming Zhang, doctor
Phone
+8618663761275
Email
liangjing0531@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Liang, doctor
Organizational Affiliation
Qianfoshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China, Shandong Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Cao
Email
qykyc309@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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