Tibial Fracture
Conditions
Keywords
Allogenic adipose derived mesenchymal stem cell tibial fracture
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.
Interventions
BIOLOGICALMesenchymal stem cell injection
Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
BIOLOGICALPlacebo
Sponsors
Royan Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group | 6 months |
Countries
Iran
Outcome results
None listed