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| Name | Class |
|---|---|
| LOEWE CGT | UNKNOWN |
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In the present phase-II clinical trial the researchers investigate efficacy and proof of concept of the 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 + beta-TCP Chronos® Synthes | Experimental | The large bone defect will be bridged as per clinical standard, filled with a clinically established scaffold (beta-TCP Chronos® Synthes), and loaded with 1.3 x 10E6 BMC/ml TCP per 1 ml beta-TCP in situ. |
|
| beta-TCP Chronos® Synthes | Placebo Comparator | The large bone defect will be bridged as per clinical Standard and filled with a clinically established scaffold (beta-TCP Chronos® Synthes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMC2012 | Biological |
| ||
| beta-TCP Chronos® Synthes |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary dislocation of fracture | Secondary dislocation is diagnosed on plain radiographs, if more than 20° varus collapse of the humeral head fragment in relation to the humeral shaft and / or screw penetration through the humeral head is detected | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome after fixation | Functional outcome after fixation will be recorded by the Dash-Score at week 12; assessment of safety: all adverse reactions will be recorded and analyzed. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Concomitant medication | Documentation of concomitant medication | day -1 |
| Adverse events | Documentation of adverse events | day -1 |
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, Frankfurt | Frankfurt am Main | Hesse | 60528 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37995325 | Derived | Seebach C, Nau C, Henrich D, Verboket R, Bellen M, Frischknecht N, Moeck V, Eichler K, Horlohe KHS, Hoffmann R, Bonig H, Seifried E, Frank J, Marzi I. Cell-Based Therapy by Autologous Bone Marrow-Derived Mononuclear Cells for Bone Augmentation of Plate-Stabilized Proximal Humeral Fractures: A Multicentric, Randomized, Open Phase IIa study. Stem Cells Transl Med. 2024 Jan 12;13(1):3-13. doi: 10.1093/stcltm/szad067. |
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The researchers will only publish data in their scientific publication
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 16, 2024 | |
| Reset | Jul 12, 2024 | |
| Release | Oct 10, 2024 | |
| Reset | Nov 22, 2024 | |
| Release | Jan 27, 2025 | |
| Reset | Feb 17, 2025 | |
| Release | Jun 23, 2025 | |
| Reset | Jul 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 16, 2024 | Jul 12, 2024 | |||
| Oct 10, 2024 |
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| Device |
|
| Concomitant medication | Documentation of concomitant medication | day 0 |
| Adverse events | Documentation of adverse events | day 0 |
| Concomitant medication | Documentation of concomitant medication | week 1 |
| Adverse events | Documentation of adverse events | week 1 |
| Concomitant medication | Documentation of concomitant medication | week 6 |
| Adverse events | Documentation of adverse events | week 6 |
| Concomitant medication | Documentation of concomitant medication | week 12 |
| Adverse events | Documentation of adverse events | week 12 |
| Degree of bony bridging (percent of defect area) in the bone fracture | Analysis of fracture healing by radiologic evaluation, consolidation, necrosis | week 1 |
| Degree of bony bridging (percent of defect area) in the bone fracture | Analysis of fracture healing by radiologic evaluation, consolidation, necrosis | week 6 |
| Degree of bony bridging (percent of defect area) in the bone fracture | Analysis of fracture healing by radiologic evaluation, consolidation, necrosis | week 12 |
| Nov 22, 2024 |
| Jan 27, 2025 | Feb 17, 2025 |
| Jun 23, 2025 | Jul 10, 2025 |