Trials / Withdrawn
WithdrawnNCT02630836
Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture
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
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Banc de Sang i Teixits · Academic / Other
- Sex
- All
- Age
- 70 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XCEL-MT-OSTEO-BETA | XCEL-MT-OSTEO-BETA followed by endomedullary nailing |
| PROCEDURE | Surgical treatment | Isolated endomedullary nailing |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2017-12-01
- Completion
- 2018-12-01
- First posted
- 2015-12-15
- Last updated
- 2017-03-17
Source: ClinicalTrials.gov record NCT02630836. Inclusion in this directory is not an endorsement.