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| Name | Class |
|---|---|
| TFS Trial Form Support | INDUSTRY |
| Ministerio de Sanidad, Servicios Sociales e Igualdad | OTHER_GOV |
| Ministerio de Ciencia e InnovaciĂłn, Spain | OTHER_GOV |
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The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented spinal fusion and the use of each patient's bone obtained from his/her iliac crest.
The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its associated morbidity.
Prospective, open-label, randomized, parallel, single-dose phase I-II clinical trial in which 62 patients affected with L4-L5 degenerative spondylolisthesis grade I-II according to Meyerding and/or with L4-L5 degenerative discopathy needing spinal fusion 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 spinal fusion. Secondary objectives are to assess the efficacy of the implantation by imaging (computerized helicoidal tomography and X-ray) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and Oswestry Disability Index).
Patients will be randomized to one of the two treatment arms (instrumented spinal fusion and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion or the standard treatment of instrumented spinal fusion and patient's bone iliac crest). Thereafter, patients will be followed for 12 months.
Imaging assessment will be done by an independent blinded radiologist.
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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 for spinal fusion |
|
| Standard treatment | Sham Comparator | Instrumented spinal fusion together with patient's bone iliac crest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XCEL-MT-OSTEO-ALPHA | Biological | Isolation and "ex-vivo" expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, DivisiĂłn de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion. |
| Measure | Description | Time Frame |
|---|---|---|
| safety of XCEL-MT-OSTEO-ALPHA (tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) | 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 (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) | 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 |
|---|---|---|
| Efficacy spinal fusion by imaging procedures (X-Ray). | Spinal fusion will be assessed by spinal X-Ray | 3, 6 and 12 months |
| Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan BagĂł, MD, PhD | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Parc de Salut Mar |
| 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, DivisiĂłn de Terapias Avanzadas. | View source |
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| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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|
| Standard treatment | Procedure | Instrumented spinal fusion together with patient's bone iliac crest |
|
Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography.
| 6 and 12 months |
| Clinical outcomes (VAS) | Pain measurement by visual analogue scale (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 (Oswestry Disability Index) | To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability Index | 3, 6 and 12 months |
| Barcelona |
| 08003 |
| Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Institut Universitari Dexeus (ICATME) | Barcelona | 08028 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Institut CatalĂ de Traumatologia i Medicina de l'Esport (Institut Universitari Dexeus) | View source |
| Hospital Universitari Vall d'Hebron, Barcelona | View source |
| Hospital Universitari Germans Trias i Pujol, Badalona | View source |
| Hospital Parc de Salut Mar, Barcelona | View source |
| Hospital de la Santa Creu i Sant Pau, Barcelona | View source |
| D009140 |
| Musculoskeletal Diseases |