drugset / Trial / NCT02230514
Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
Phase 1/2
Completed
19 enrolled
Blood and Tissue Bank of Catalonia
Hospital ASEPEYO Sant Cugat · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XCEL-MT-OSTEO-ALPHA | Cell therapy | — | — |
Indications
No indication recorded.