Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Tibial Fracture
- Sponsor
- Royan Institute
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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 or uncontrolled diabetes or heart and lung disease
- •immune deficiency
Outcomes
Primary Outcomes
Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
Time Frame: 6 months