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

August 2, 2021 updated by: Lili Cao, Qianfoshan Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • China, Shandong Qianfoshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month to 1 year after treatment
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.
1 month to 1 year after treatment
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.
1 month to 1 year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Collaborators

Shandong Qilu Stem Cells Engineering Co., Ltd.

Investigators

  • Principal Investigator: Jing Liang, doctor, Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2020

Primary Completion (Anticipated)

December 10, 2021

Study Completion (Anticipated)

December 10, 2022

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2020(041)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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