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Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones

NCT02230514 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-04-12

No results posted yet for this study

Summary

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest.

XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia).

The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.

Conditions

  • Atrophic Nonunion of Fracture

Interventions

DRUG

XCEL-MT-OSTEO-ALPHA

"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery

OTHER

autologous iliac crest

Autologous iliac crest in association with surgery

PROCEDURE

Surgery

Standard surgery for non-union fractures

Sponsors & Collaborators

  • Hospital ASEPEYO Sant Cugat

    collaborator UNKNOWN

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Fernando Granell, MD, PhD · Hospital ASEPEYO Sant Cugat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-20
Primary Completion
2019-03-05
Completion
2019-12-20

Countries

  • Spain

Study Locations

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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 NCT02230514 on ClinicalTrials.gov