Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
Phase 1
- Conditions
- Bone NonunionFracture
- Registration Number
- NCT02815423
- Lead Sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Radiological progression of bone fusion 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
- Secondary Outcome Measures
Name Time Method Comparison of the rate of complications between the 2 groups 12 months Incidence of increased temperature sensitivity by questionnaire 6 months Incidence and severity of infections at grafting sites by questionnaire 6 months