Clinical trial NCT02630836: Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Femoral Neck Fracture
Keywords: mesenchymal stromal cells
stem cells
elderly
allogeneic
bone marrow
bone regeneration
fracture
Lead sponsor: Banc de Sang i Teixits
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2015-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.
timeFrame: 12 months
Secondary outcomes:
measure: efficacy through CT scan
timeFrame: 3 months
measure: efficacy through xRay
timeFrame: 1, 3 and 6 months
measure: efficacy by clinical assessment
timeFrame: 1, 3 and 6 month
measure: efficacy by quality of life questionnaire
timeFrame: 3, 6 and 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Josep Maria Segur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: