Bone NonunionNCT04997590
Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing
A study testing Umbilical cord blood mononuclear cells and Staphylococcal Enterotoxin C in people with Bone Nonunion, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Nonunion
- What is being tested?
- Umbilical cord blood mononuclear cells and Staphylococcal Enterotoxin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2020to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Shandong Qianfoshan Hospital
Jinan, Shandong, 250014
Lili Cao, qykyc309@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Nonunion
- Being tested
- Umbilical cord blood mononuclear cells, Staphylococcal Enterotoxin C
- Keywords
- Umbilical cord blood mononuclear cells, Traumatic fracture healing, Bone nonunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Staphylococcal Enterotoxin CDrug
injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Umbilical cord blood mononuclear cells |
| Staphylococcal Enterotoxin C group | Active comparator | Staphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total. Receives: Drug: Staphylococcal Enterotoxin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 month to 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start10 Dec 2020
- Primary completion10 Dec 2021 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone NonunionStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Qilu Stem Cells Engineering Co., Ltd.
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Jing Liang, doctor, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997590
- Sponsor's protocol ID
- YXLL-KY-2020(041)
- Status last verified
- Aug 2021
- First submitted
- 26 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing
- ClinicalTrials.gov ID
- NCT04997590
- Acronym / sponsor ID
- YXLL-KY-2020(041)
- Conditions
- Bone Nonunion
- Keywords
- Umbilical cord blood mononuclear cells, Traumatic fracture healing, Bone nonunion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Collaborators
- Shandong Qilu Stem Cells Engineering Co., Ltd.
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Dec 2021 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord blood mononuclear cells group | Experimental | Biological: Umbilical cord blood mononuclear cellsUmbilical cord blood mononuclear cells (cell number 1×108/2mL), once every two weeks, 3 times in total. |
| Staphylococcal Enterotoxin C group | Active comparator | Drug: Staphylococcal Enterotoxin CStaphylococcal enterotoxin C (2mL), once every two weeks, 3 times in total. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord blood mononuclear cellsinjection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times. | Biological | Umbilical cord blood mononuclear cells group |
| Staphylococcal Enterotoxin Cinjection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times. | Drug | Staphylococcal Enterotoxin C group |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Liang, doctor principal investigator
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord blood mononuclear cells and Staphylococcal Enterotoxin C in people with Bone Nonunion, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunming Zhang, doctor (+8618663761275, liangjing0531@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone formation (time frame: 1 month to 1 year after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.