Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture

Banc de Sang i Teixits

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Femoral Neck Fracture

Treatments: Procedure: Surgical treatment; Drug: XCEL-MT-OSTEO-BETA

Study type: Interventional

Funder types: Other

Identifiers

NCT02630836

XCEL-MT-10-03

2010-024041-78 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 70 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

XCEL-MT-OSTEO-BETA

Experimental group

Description:

Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing

Treatment:

Procedure: Surgical treatment

Drug: XCEL-MT-OSTEO-BETA

Standard treatment

Other group

Description:

Standard surgical treatment with isolated endomedullary nailing

Treatment:

Procedure: Surgical treatment