Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024041-78 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundacion Clinic per a la Recerca Biomédica | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire.
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor phase I-II pilot study.
Thirty-two (32) elderly patients (70-85 years of age) with type 31A2 y 31A3 fracture of the femur (AO/ASIF (Association for the Study of Internal Fixation) classification) admitted at the emergency room of the Hospital Clinic of Barcelona will be randomized 1:1 to one of the two treatment-arms (endomedullary nailing + XCEL-MT-OSTEO-BETA or isolated endomedullary nailing as the standard treatment). Once surgically treated, patients will be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire (EUROQOL-5D).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XCEL-MT-OSTEO-BETA | Experimental | Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing |
|
| Standard treatment | Other | Standard surgical treatment with isolated endomedullary nailing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XCEL-MT-OSTEO-BETA | Drug | XCEL-MT-OSTEO-BETA followed by endomedullary nailing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests. | Adverse events, physical exam, laboratory tests. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy through CT scan | assessment of consolidation by determination of Hounsfield units in CT scan | 3 months |
| efficacy through xRay | assessment of bone callus characteristics by standard radiology |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Josep Maria Segur, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
Not provided
Not provided
| Label | URL |
|---|---|
| Blood and Tissue Banc of Catalonia | View source |
| Hospital ClÃnic de Barcelona | View source |
| Hospital Clinic Foundation |
Not provided
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Surgical treatment |
| Procedure |
Isolated endomedullary nailing |
|
| 1, 3 and 6 months |
| efficacy by clinical assessment | Clinical assessment by visual analogue scale for pain | 1, 3 and 6 month |
| efficacy by quality of life questionnaire | EUROQoL-5D quality of life questionnaire | 3, 6 and 12 month |
| D007869 |
| Leg Injuries |