Femoral Neck Fracture
Conditions
Keywords
mesenchymal stromal cells, stem cells, elderly, allogeneic, bone marrow, bone regeneration, fracture
Brief summary
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.
Detailed description
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).
Interventions
DRUGXCEL-MT-OSTEO-BETA
XCEL-MT-OSTEO-BETA followed by endomedullary nailing
PROCEDURESurgical treatment
Isolated endomedullary nailing
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Banc de Sang i Teixits
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient between70 and 85 years old 2. Proximal femur fracture type 31A3 31a2 classification AO/ASIF. 3. Deambulation prior to fracture. 4. Written informed consent of the patient or family members.
Exclusion criteria
1. Presence of implants at proximal femur level. 2. Presence of local or systemic septic process. 3. Septic arthritis. 4. Dementia of any type. 5. Hematological and biochemical analysis with significant alterations that contraindicate surgery. 6. Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis. 7. Neoplastic disease detected in the last five years or without complete remission. 8. Immunosuppressive status. 9. Patients who received corticosteroids in the 3 months prior to study initiation. 10. Simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study. 11. Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria. 12. Patient refusal to be followed by a period that may exceed the clinical trial itself.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests. | 12 months | Adverse events, physical exam, laboratory tests. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| efficacy through CT scan | 3 months | assessment of consolidation by determination of Hounsfield units in CT scan |
| efficacy through xRay | 1, 3 and 6 months | assessment of bone callus characteristics by standard radiology |
| efficacy by clinical assessment | 1, 3 and 6 month | Clinical assessment by visual analogue scale for pain |
| efficacy by quality of life questionnaire | 3, 6 and 12 month | EUROQoL-5D quality of life questionnaire |
Outcome results
None listed