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.
A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrophic pseudoarthrosis of long bones.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
19
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery
Autologous iliac crest in association with surgery
Standard surgery for non-union fractures
Hospital ASEPEYO Sant Cugat
Sant Cugat del Vallès, Barcelona, Spain
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
Hounsfield units quantification by tomography in both treatment arms
Time frame: 12 month
Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures
Safety will be assessed by collecting adverse events throughout the experimental phase which includes a follow-up of 12 month.
Time frame: 12 month
Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
Characteristics of the callus by tomography and Characteristics of the callus by standard x-ray in both treatment arms
Time frame: 6 month
Efficacy assessment by quality of life test
Quality of life will be measured by EUROQOL-5D test
Time frame: 12 month
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