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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2022-12-10

Brief Summary

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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

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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.

Conditions

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Bone Nonunion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Umbilical cord blood mononuclear cells

Intervention Type BIOLOGICAL

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.

Group Type ACTIVE_COMPARATOR

Staphylococcal Enterotoxin C

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Staphylococcal Enterotoxin C

injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Qilu Stem Cells Engineering Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lili Cao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunming Zhang, doctor

Role: CONTACT

+8618663761275

Facility Contacts

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Lili Cao

Role: primary

Other Identifiers

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YXLL-KY-2020(041)

Identifier Type: -

Identifier Source: org_study_id

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