A Phase 1/2 interventional study of XCEL-MT-OSTEO-ALPHA and autologous iliac crest in Atrophic Nonunion of Fracture, sponsored by Banc de Sang i Teixits. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-12.
Sponsored by Banc de Sang i Teixits · Phase 1/2, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 19 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Banc de Sang i Teixits is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue
Drug: XCEL-MT-OSTEO-ALPHA · Procedure: Surgery
Standard treatment
Other: autologous iliac crest · Procedure: Surgery
"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
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
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Banc de Sang i Teixits