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Clinical Trial Summary

Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union. On the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Also for better result we used the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate.

Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment. Clinical union consider to relief pain in non union site and be stable in examination.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01958502
Study type Interventional
Source Emdadi Kamyab Hospital
Contact mohammad taghi peivandi, MD
Phone +989153143691
Email peivandimt@mums.ac.ir
Status Recruiting
Phase Phase 2
Start date July 2013
Completion date November 2014

See also
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Completed NCT05163795 - Distal Femur Fracture Nonunion - Statistical Analysis Plan
Recruiting NCT03891888 - Intramedullary Bone Grafting for Open Tibial Shaft Fractures N/A
Recruiting NCT04299022 - Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Enrolling by invitation NCT03937310 - NGS for Non-unions
Active, not recruiting NCT03129971 - Platelet-rich Plasma Combined With Conventional Surgery in the Treatment of Atrophic Nonunion of Femoral Shaft Fractures N/A