Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture

Banc de Sang i Teixits

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Femoral Neck Fracture

Interventions

XCEL-MT-OSTEO-BETADRUG

XCEL-MT-OSTEO-BETA followed by endomedullary nailing

Surgical treatmentPROCEDURE

Isolated endomedullary nailing

Eligibility

Sex: ALLMin age: 70 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.

Adverse events, physical exam, laboratory tests.

Time frame: 12 months

Secondary Outcomes

efficacy through CT scan

assessment of consolidation by determination of Hounsfield units in CT scan

Time frame: 3 months

efficacy through xRay

assessment of bone callus characteristics by standard radiology

Time frame: 1, 3 and 6 months

efficacy by clinical assessment

Clinical assessment by visual analogue scale for pain

Time frame: 1, 3 and 6 month

efficacy by quality of life questionnaire

EUROQoL-5D quality of life questionnaire

Time frame: 3, 6 and 12 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.