- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02815423
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
June 23, 2016 updated by: South China Research Center for Stem Cell and Regenerative Medicine
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sihan Wang, Ph.D
- Phone Number: 8620-89199011
- Email: wangsihan@scrm.org.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: UCMSCs
Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.
|
Transplatation of umbilical cord mesenchymal stem cells
|
Placebo Comparator: Placebo
The patients with fracture and bone nonunion who underwent percutaneous injection of placebo.
|
Percutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of the rate of complications between the 2 groups
Time Frame: 12 months
|
12 months
|
Incidence of increased temperature sensitivity by questionnaire
Time Frame: 6 months
|
6 months
|
Incidence and severity of infections at grafting sites by questionnaire
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
January 1, 2020
Study Registration Dates
First Submitted
April 20, 2016
First Submitted That Met QC Criteria
June 23, 2016
First Posted (Estimate)
June 28, 2016
Study Record Updates
Last Update Posted (Estimate)
June 28, 2016
Last Update Submitted That Met QC Criteria
June 23, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCMSC-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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