Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing
NCT ID: NCT04997590
Last Updated: 2021-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-12-10
2022-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Umbilical cord blood mononuclear cells group
Umbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total.
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.
Staphylococcal Enterotoxin C group
Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total.
Staphylococcal Enterotoxin C
injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.
Interventions
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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.
Staphylococcal Enterotoxin C
injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shandong Qilu Stem Cells Engineering Co., Ltd.
INDUSTRY
Qianfoshan Hospital
OTHER
Responsible Party
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Lili Cao
Professor
Principal Investigators
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Jing Liang, doctor
Role: PRINCIPAL_INVESTIGATOR
Qianfoshan Hospital
Locations
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China, Shandong Qianfoshan Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXLL-KY-2020(041)
Identifier Type: -
Identifier Source: org_study_id
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