Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Phase 2
- Conditions
- Tibial Closed Diaphyseal Fractures.Fracture of shaft of tibia
- Registration Number
- IRCT201508061031N11
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Inclusion Criteria:
Age 18 to 65 years; The presence of tibial fracture based on X ray; Tibial fracture is limited to diaphysial.
Exclusion Criteria
Addiction; Pregnancy; liver or kidney disease; uncontrolled diabetes; heart and lung disease; Immune deficiency.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nion of tibia after transplantation of mesenchymal stem cell. Timepoint: Before 3 and 6 months after injection. Method of measurement: X-ray radiography, walking distance, and whole body weight bearing by fractured limb.
- Secondary Outcome Measures
Name Time Method Evaluation of adverse events such as infection and edema in the fracture site. Timepoint: Before 3 and 6 months after injection. Method of measurement: Physical examination.