Trial Information
The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital
Inclusion Criteria:
- Every patient with non union in the site of long bone fracture
- Age more than 18 and under 60 years old
- Fracture having no radiological callus after 6 months and absence of any hypertrophic
bone reaction.
- No infection in site of surgery
- Be able and willing to participate in the study
- Written informed consent
Exclusion Criteria:
- Evidence of malignancy
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
clinical and radiological union at 1 month to 6 months
Outcome Description:
patients receiving Mesenchymal Stem Cells that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
mohammad taghi peivandi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Emdadi Kamyab Hospital
Authority:
Iran: Ministry of Health
Study ID:
900939
NCT ID:
NCT01788059
Start Date:
January 2013
Completion Date:
May 2014
Related Keywords:
- Nonunion Fracture
- nonunion
- mesenchymal stem cell
- long bone
- Femoral Fractures
- Fractures, Bone
- Fractures, Ununited