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Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture

NCT02630836 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-03-17

No results posted yet for this study

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.

Conditions

  • Femoral Neck Fracture

Interventions

DRUG

XCEL-MT-OSTEO-BETA

XCEL-MT-OSTEO-BETA followed by endomedullary nailing

PROCEDURE

Surgical treatment

Isolated endomedullary nailing

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    collaborator OTHER

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Josep Maria Segur, MD, PhD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-12-31
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02630836 on ClinicalTrials.gov