Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture
- Conditions
- Femoral Neck Fracture
- Interventions
- Drug: XCEL-MT-OSTEO-BETAProcedure: Surgical treatment
- Registration Number
- NCT02630836
- Lead Sponsor
- Banc de Sang i Teixits
- 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patient between70 and 85 years old
- Proximal femur fracture type 31A3 31a2 classification AO/ASIF.
- Deambulation prior to fracture.
- Written informed consent of the patient or family members.
- Presence of implants at proximal femur level.
- Presence of local or systemic septic process.
- Septic arthritis.
- Dementia of any type.
- Hematological and biochemical analysis with significant alterations that contraindicate surgery.
- Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis.
- Neoplastic disease detected in the last five years or without complete remission.
- Immunosuppressive status.
- Patients who received corticosteroids in the 3 months prior to study initiation.
- Simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study.
- Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria.
- Patient refusal to be followed by a period that may exceed the clinical trial itself.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XCEL-MT-OSTEO-BETA XCEL-MT-OSTEO-BETA 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 Surgical treatment Standard surgical treatment with isolated endomedullary nailing XCEL-MT-OSTEO-BETA Surgical treatment Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method efficacy through xRay 1, 3 and 6 months assessment of bone callus characteristics by standard radiology
efficacy by quality of life questionnaire 3, 6 and 12 month EUROQoL-5D quality of life questionnaire
efficacy through CT scan 3 months assessment of consolidation by determination of Hounsfield units in CT scan
efficacy by clinical assessment 1, 3 and 6 month Clinical assessment by visual analogue scale for pain