drugset / Trial / NCT02230514

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

NCT02230514 ↗

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject XCEL-MT-OSTEO-ALPHA Cell therapy — —

Indications

No indication recorded.