A Phase 2 interventional study of injection the mesenchymal stem cell in non union site in Nonunion Fracture, sponsored by Emdadi Kamyab Hospital. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-30.
Sponsored by Emdadi Kamyab Hospital · Phase 2, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 19 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Emdadi Kamyab Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
stem cells drived from iliac bone marrow with centrifuge and ficoll method then inject to non union site 2-3 ml with approximately 40 X 10E6 Mesenchymal Stem Cells (MSC) will be injected in the nonunion site of the bone fracture under fluoroscopic gide and general or spinal anesthesia as deemed appropriate by the anesthetist.
Other: injection the mesenchymal stem cell in non union site
clinical and radiological union at 1 month to 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
Time frame: 6 months
•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
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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