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The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sepax, ignite, fracture healing | Experimental | the mesenchymal cells will be separated by sepax separation system and demineralized bone matrix will be done using IGNITE INJECTABLE REPAIR GRAFT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology. | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical and radiological bony union at 3 months and 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadas Lemberg, PhD | Contact | 00 972 2 6777572 | lhadas@hadassah.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jerusalem | Israel |
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