Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Phase 2
Completed
- Conditions
- Tibial Fracture
- Interventions
- Biological: PlaceboBiological: Mesenchymal stem cell injection
- Registration Number
- NCT02140528
- Lead Sponsor
- Royan Institute
- Brief Summary
This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.
- Detailed Description
In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) .
To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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 or uncontrolled diabetes or heart and lung disease
- immune deficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo injection in the site of fracture in patients with tibia fracture. Mesenchymal stem cell receipients Mesenchymal stem cell injection Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.
- Primary Outcome Measures
Name Time Method Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Royan Institute
🇮🇷Tehran, Iran, Islamic Republic of