Fracture Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | January 2020 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 researcherĀ“s opinion could affect the patientĀ“s ability to complete the trial or hamper the participation in the trial. - Patients do not sign the consent forms |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
South China Research Center for Stem Cell and Regenerative Medicine | Guangzhou Panyu Central Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 months | No |
Secondary | Comparison of the rate of complications between the 2 groups | 12 months | No | |
Secondary | Incidence of increased temperature sensitivity by questionnaire | 6 months | No | |
Secondary | Incidence and severity of infections at grafting sites by questionnaire | 6 months | Yes |
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