Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

Phase 1/2 Completed 23 enrolled Blood and Tissue Bank of Catalonia European Regional Development Fund · collab Ministerio de Ciencia e Innovación, Spain · collab Ministerio de Sanidad, Servicios Sociales e Igualdad · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression. XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue. The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the progression to collapse of the femoral head.

Timeline

Start: 2015-05-05
Primary completion: 2018-04-11
Completion: 2019-06-27

Publications

Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	XCEL-MT-OSTEO-ALPHA	Cell therapy	—	—

Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

Summary

Timeline

Publications

Drugs

Indications