Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Pilot Clinical Trial of ex Vivo Expanded Allogenic Adult Stem Cells Combined With Allogenic Human Bone Tissue (XCEL-MT-OSTEO-BETA) in Proximal Femur Fractures in Elderly Patients

Conditions
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Femoral Neck Fracture

Intervention / Treatment
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* Drug: XCEL-MT-OSTEO-BETA
* Procedure: Surgical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XCEL-MT-OSTEO-BETA<br>Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing | Drug: XCEL-MT-OSTEO-BETA<br>* XCEL-MT-OSTEO-BETA followed by endomedullary nailing<br>Procedure: Surgical treatment<br>* Isolated endomedullary nailing<br>|
| Other: Standard treatment<br>Standard surgical treatment with isolated endomedullary nailing | Procedure: Surgical treatment<br>* Isolated endomedullary nailing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesenchymal stromal cells, stem cells, elderly, allogeneic, bone marrow, bone regeneration, fracture