Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head
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.
|Avascular Necrosis of Femur Head||Biological: XCEL-MT-OSTEO-ALPHA Procedure: Standard treatment||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Pilot Clinical Trial of "ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue (XCEL-MT-OSTEO- ALPHA) in Osteonecrosis of the Femoral Head|
- Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head [ Time Frame: 12 months ]Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months
- Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head [ Time Frame: 12 months ]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.
- Bone regeneration by measuring the necrotic angle using the modified Kerboul method [ Time Frame: 6 and 12 months ]The necrotic angle will be measured using imaging procedures (magnetic resonance imaging MRI).
- Dynamic changes of signal intensity [ Time Frame: 6 and 12 months ]Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head
- Clinical outcomes (pain) by Visual Analogue Scale (VAS) [ Time Frame: 7 days and at 3, 6 and 12 months ]Pain measurement by VAS
- Clinical outcomes (SF-36) [ Time Frame: 3, 6 and 12 months ]This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36
- Clinical outcome (WOMAC) [ Time Frame: 3, 6 and 12 months ]To assess the extent by which a person's functional level is restricted by the WOMAC index
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue (under Xcelia-GMP conditions)for osteonecrosis of the femoral head
Core decompression plus XCEL-MT-OSTEO-ALPHA
Sham Comparator: Standard Treatment
Isolated core decompression
Procedure: Standard treatment
Isolated core decompression
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605383
|Hospital Universitari Vall d'Hebron|
|Barcelona, Spain, 08035|
|Principal Investigator:||Màrius Aguirre, MD, PhD||Hospital Vall d'Hebron|