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| Name | Class |
|---|---|
| LOEWE CGT | UNKNOWN |
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In the present phase-I clinical trial we investigate safety and feasibility of an augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMC2012 | Experimental | The large bone defect was then be bridged as per clinical standard, filled with a clinically established scaffold (ß-TCP), and 1.3 x106/ml BMC were loaded per 1 ml ß-TCP in situ. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMC2012 | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | at day -1 |
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | at day 0 |
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | week 1 post surgery |
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | week 6 post surgery |
| safety | Analysis of safety : morbidity of bone marrow punction local reaction (infection, delayed wound healing) systemic reaction (leucocytes, C-reactive protein, Interleukin-6, procalcitonin) fever (> 38,5°C longer than 2 days) | week 12 post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | at day-1 |
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls |
| Measure | Description | Time Frame |
|---|---|---|
| osseous healing by radiologic evaluation | Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting | at day 0 |
| DASH-Score | testing the function of the shoulder |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingo Marzi, MD Prof. | Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of trauma-, hand- and reconstructive surgery, Goethe University Hospital | Frankfurt | Theodor-Stern-Kai 7 | 60590 | Germany |
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| at day 0 |
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | week 1 post surgery |
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | week 6 post surgery |
| feasibility | Analysis of feasibility of isolation and application of BMC, logistic and clinical controls | week 12 post surgery |
| at 12 weeks post surgery |
| documentation of concomitant medication and Adverse Events | analysis of medication and Adverse Events | at day -1 |
| osseous healing by radiologic evaluation | Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting | week 1 post surgery |
| osseous healing by radiologic evaluation | Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting | week 6 post surgery |
| osseous healing by radiologic evaluation | Analysis of fracture healing, consolidation, necrosis, dislocation of reposition, screw cutting | week 12 post surgery |
| documentation of concomitant medication and Adverse Events | analysis of medication and Adverse Events | day 0 |
| documentation of concomitant medication and Adverse Events | analysis of medication and Adverse Events | week 1 |
| documentation of concomitant medication and Adverse Events | analysis of medication and Adverse Events | week 6 post surgery |
| documentation of concomitant medication and Adverse Events | analysis of medication and Adverse Events | week 12 post surgery |