Clinical Trial: The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital

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. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. 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 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. [ Time Frame: 12 months ]
  • Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Emdadi Kamyab Hospital

Dates:
Date Received: January 17, 2013
Date Started: January 2013
Date Completion:
Last Updated: December 26, 2013
Last Verified: December 2013