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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cell | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection the mesenchymal stem cell in non union site | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| •Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects. | 12 months | |
| Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| mohammad taghi peivandi, MD | Emdadi Kamyab Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emdai Kamyab Hospital | Mashhad | Khorasan | Iran |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 13, 2014 | |
| Reset | Mar 27, 2014 | |
| Release | May 17, 2014 |
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| 12 months |
| Reset | Jun 14, 2014 |
| Release | Aug 2, 2017 |
| Reset | Feb 16, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 13, 2014 | Mar 27, 2014 | |||
| May 17, 2014 | Jun 14, 2014 | |||
| Aug 2, 2017 | Feb 16, 2018 |
| ID | Term |
|---|---|
| D005599 | Fractures, Ununited |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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