A Phase 2 interventional study of surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold in Nonunion of Fracture, sponsored by Emdadi Kamyab Hospital. Status unknown 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 2013-10-09.
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. 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.
54 studies on the registry are indexed under Fractures, Ununited; 10 are open to participants now.
This study's planned enrollment of 18 is below the median of 46 across 33 interventional studies indexed under Fractures, Ununited.
Browse Fractures, Ununited 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 implant in collagenic 3-D scaffold with BMP-2 and put in non union site by surgical approach under general or spinal anesthesia as deemed appropriate by the anesthetist.
Genetic: surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold
clinical and radiological union at 1 month to 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
Time frame: 6 months
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
This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Emdadi Kamyab Hospital