Bone Nonunion, Fracture
Conditions
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.
Interventions
BIOLOGICALUCMSCs
Transplatation of umbilical cord mesenchymal stem cells
BIOLOGICALPercutaneous
Percutaneous injection
Sponsors
Guangzhou Panyu Central Hospital
South China Research Center for Stem Cell and Regenerative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Contacts
Primary ContactXuetao Pei, M.D., Ph.D
Backup ContactSihan Wang, Ph.D
Outcome results
None listed