A Phase 1/2 interventional study of XCEL-MT-OSTEO-ALPHA and Standard treatment in Avascular Necrosis of Femur Head, sponsored by Banc de Sang i Teixits. Completed at 1 site in Spain. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-01-21.
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 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.
Prospective, open-label with blinded assessor, randomized, parallel, single-dose phase I-II clinical trial in which 24 patients affected with osteonecrosis of the femoral head ARCO grade I or II will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in osteonecrosis of the femoral head. Secondary objectives are to assess the efficacy of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and WOMAC Index).
Patients will be randomized to one of the two treatment arms (core decompression and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue or the standard treatment of isolated core decompression). Thereafter, patients will be followed for 12 months.
184 studies on the registry are indexed under Osteonecrosis; 33 are open to participants now.
This study's enrollment of 23 is below the median of 51 across 98 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis 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 stem cells fixed in allogenic bone tissue (under Xcelia-GMP conditions)for osteonecrosis of the femoral head
Biological: XCEL-MT-OSTEO-ALPHA
Isolated core decompression
Procedure: Standard treatment
Core decompression plus XCEL-MT-OSTEO-ALPHA
Isolated core decompression
Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months
Time frame: 12 months
Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head
Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable.
Time frame: 12 months
Bone regeneration by measuring the necrotic angle using the modified Kerboul method
The necrotic angle will be measured using imaging procedures (magnetic resonance imaging MRI).
Time frame: 6 and 12 months
Dynamic changes of signal intensity
Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head
Time frame: 6 and 12 months
Clinical outcomes (pain) by Visual Analogue Scale (VAS)
Pain measurement by VAS
Time frame: 7 days and at 3, 6 and 12 months
Clinical outcomes (SF-36)
This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36
Time frame: 3, 6 and 12 months
Clinical outcome (WOMAC)
To assess the extent by which a person's functional level is restricted by the WOMAC index
Time frame: 3, 6 and 12 months
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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