NCT04997590

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

July 26, 2021

Last Update Submit

August 2, 2021

Conditions

Bone Nonunion

Keywords

Umbilical cord blood mononuclear cellsTraumatic fracture healingBone nonunion

Outcome Measures

Primary Outcomes (3)

  • 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.

    1 month to 1 year after treatment

  • Bone defect connection

    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

    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

Study Arms (2)

Umbilical cord blood mononuclear cells group

EXPERIMENTAL

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

Biological: Umbilical cord blood mononuclear cells

Staphylococcal Enterotoxin C group

ACTIVE COMPARATOR

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

Drug: Staphylococcal Enterotoxin C

Interventions

Umbilical cord blood mononuclear cellsBIOLOGICAL

injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times.

Umbilical cord blood mononuclear cells group
Staphylococcal Enterotoxin CDRUG

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

Staphylococcal Enterotoxin C group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic long bone fracture.
  • Noninfectious bone nonunion, delayed bone union.
  • 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.

You may not qualify if:

  • There are infection foci at and near the fracture end after fracture.
  • months after the fracture, tests showed partial callus growth.
  • Combining shortening, angulation and displacement phenomena.
  • Partial callus grew 8 months after local bone grafting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China, Shandong Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Interventions

enterotoxin C, staphylococcal

Study Officials

  • Jing Liang, doctor

    Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunming Zhang, doctor

CONTACT

+8618663761275liangjing0531@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 9, 2021

Study Start

December 10, 2020

Primary Completion

December 10, 2021

Study Completion

December 10, 2022

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations

CN(1)