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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023998-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Ministerio de Sanidad, Servicios Sociales e Igualdad | OTHER_GOV |
| Ministerio de Ciencia e Innovación, Spain | OTHER_GOV |
| European Regional Development Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XCEL-MT-OSTEO-ALPHA | Experimental | "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue (under Xcelia-GMP conditions)for osteonecrosis of the femoral head |
|
| Standard Treatment | Sham Comparator | Isolated core decompression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XCEL-MT-OSTEO-ALPHA | Biological | Core decompression plus XCEL-MT-OSTEO-ALPHA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 and 12 months |
| Dynamic changes of signal intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Màrius Aguirre, MD, PhD | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25769789 | Derived | 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. |
| Label | URL |
|---|---|
| Banc de Sang i Teixits. Xcelia-División de Terapias Avanzadas. | View source |
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| ID | Term |
|---|---|
| D005271 | Femur Head Necrosis |
| D007873 | Legg-Calve-Perthes Disease |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard treatment |
| Procedure |
Isolated core decompression |
|
Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head
| 6 and 12 months |
| Clinical outcomes (pain) by Visual Analogue Scale (VAS) | Pain measurement by VAS | 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 | 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 | 3, 6 and 12 months |
| Hospital Universitari Vall d'Hebron, Barcelona | View source |