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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04997590
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : August 9, 2021
Sponsor:
Collaborator:
Shandong Qilu Stem Cells Engineering Co., Ltd.
Information provided by (Responsible Party):
Lili Cao, 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.

Condition or disease Intervention/treatment Phase
Bone Nonunion Biological: Umbilical cord blood mononuclear cells Drug: Staphylococcal Enterotoxin C Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : December 10, 2021
Estimated Study Completion Date : December 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997590


Contacts
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Contact: Chunming Zhang, doctor +8618663761275 liangjing0531@163.com

Locations
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China, Shandong
China, Shandong Qianfoshan Hospital Recruiting
Jinan, Shandong, China, 250014
Contact: Lili Cao       qykyc309@163.com   
Sponsors and Collaborators
Qianfoshan Hospital
Shandong Qilu Stem Cells Engineering Co., Ltd.
Investigators
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Principal Investigator: Jing Liang, doctor Qianfoshan Hospital
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Responsible Party: Lili Cao, Professor, Qianfoshan Hospital
ClinicalTrials.gov Identifier: NCT04997590    
Other Study ID Numbers: YXLL-KY-2020(041)
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lili Cao, Qianfoshan Hospital:
Umbilical cord blood mononuclear cells
Traumatic fracture healing
Bone nonunion
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries