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This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.
In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) .
To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cell receipients | Experimental | Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture. |
|
| Placebo | Placebo Comparator | Placebo injection in the site of fracture in patients with tibia fracture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cell injection | Biological | Injection of adipose derived mesenchymal stem cell in the site of tibia fracture . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Nasser Aghdami, MD,PhD | Head of regenerative medicine department &cell therapy center of Royan Institute | Study Director |
| Mohsen Emaddedin, MD | Department or regenerative medicine of Royan Institute. | Study Director |
| Aziz Ahmadi, MD | Scientific board of Iranian Orthopedic Association | Principal Investigator |
| Maedeh Ghorbani, MD | Department of Regenerative Medicine | Principal Investigator |
| Afshin Farhadi, MD | Scientific board of Iranian Orthopedic Association | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Tehran | Iran |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| Placebo | Biological |
|
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |