FracturePhase 1/2NCT02815423
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
A Phase 1/2 study testing UCMSCs and Percutaneous in people with Fracture and Bone Nonunion, run by South China Research Center for Stem Cell and Regenerative Medicine.
Trial summary
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fracture, Bone Nonunion
- What is being tested?
- UCMSCs and Percutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2020
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Every patient with non union in the site of bone fracture and nonunion.
- Age more than 18 and less than 60 years old.
- Nonunion or delayed union.
Who cannot join
- Diagnosis of cancer.
- Pregnancy or breastfeeding.
- Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing.
- Any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial.
- Patients do not sign the consent forms
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.
- Conditions
- Fracture, Bone Nonunion
- Being tested
- UCMSCs, Percutaneous
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCMSCsBiological
Transplatation of umbilical cord mesenchymal stem cells
PercutaneousBiological
Percutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| UCMSCs | Experimental | Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion. Receives: Biological: UCMSCs |
| Placebo | Placebo comparator | The patients with fracture and bone nonunion who underwent percutaneous injection of placebo. Receives: Biological: Percutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological progression of bone fusion
After patients receiving mesenchymal stem cells or placebo, imaging control by X-ray and CT, and then analysis by software(ImageJ ) at 1, 6 and 12 months
Measured: 12 months
Secondary outcomes (3)
Comparison of the rate of complications between the 2 groups
Measured: 12 months
Incidence of increased temperature sensitivity by questionnaire
Measured: 6 months
Incidence and severity of infections at grafting sites by questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Panyu Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815423
- Sponsor's protocol ID
- UCMSC-6
- Status last verified
- Mar 2016
- First submitted
- 20 Apr 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
- ClinicalTrials.gov ID
- NCT02815423
- Acronym / sponsor ID
- UCMSC-6
- Conditions
- Fracture, Bone Nonunion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative MedicineUniversity, hospital or other
- Collaborators
- Guangzhou Panyu Central Hospital
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- 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 purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCMSCs | Experimental | Biological: UCMSCsTransplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion. |
| Placebo | Placebo comparator | Biological: PercutaneousThe patients with fracture and bone nonunion who underwent percutaneous injection of placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Every patient with non union in the site of bone fracture and nonunion.
- Age more than 18 and less than 60 years old.
- Nonunion or delayed union.
Key exclusion criteria (5 listed)
- Diagnosis of cancer.
- Pregnancy or breastfeeding.
- Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing.
- Any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial.
- Patients do not sign the consent forms
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 |
|---|---|---|
| UCMSCsTransplatation of umbilical cord mesenchymal stem cells | Biological | UCMSCs |
| PercutaneousPercutaneous injection | Biological | Placebo |
Primary outcome
Radiological progression of bone fusion
Time frame: 12 months
After patients receiving mesenchymal stem cells or placebo, imaging control by X-ray and CT, and then analysis by software(ImageJ ) at 1, 6 and 12 months
3 secondary outcomes
Comparison of the rate of complications between the 2 groups
Time frame: 12 months
Incidence of increased temperature sensitivity by questionnaire
Time frame: 6 months
Incidence and severity of infections at grafting sites by questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UCMSCs and Percutaneous in people with Fracture and Bone Nonunion, run by South China Research Center for Stem Cell and Regenerative Medicine.
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 3 inclusion and 5 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 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xuetao Pei, M.D., Ph.D (8610-68164807, AMMS0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological progression of bone fusion (time frame: 12 months). 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 28 Jun 2016.