Clinical Trial: Evaluation the Treatment of Nonunion of Long Bone Fracture of Lower Extremities (Femur and Tibia) Using Mononuclear Stem Cells From the Iliac Wing Within a 3-D Tissue Engineered Scaffold

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

Brief 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.


Detailed Summary:
Sponsor: Emdadi Kamyab Hospital

Current Primary Outcome: clinical and radiological union at 1 month to 6 months [ Time Frame: 6 months ]

patients receiving Mesenchymal Stem Cells within a 3-D tissue engineered scaffold that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects(infection,malignancy,local or systemic allergic reaction) [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Emdadi Kamyab Hospital

Dates:
Date Received: August 21, 2013
Date Started: July 2013
Date Completion: November 2014
Last Updated: October 8, 2013
Last Verified: October 2013