drugset / Trial / NCT02630836
Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture
Phase 1/2
Withdrawn
Blood and Tissue Bank of Catalonia
Fundacion Clinic per a la Recerca Biomédica · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2015-12
- Primary completion
- 2017-12
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XCEL-MT-OSTEO-BETA | Cell therapy | — | — |