Safety Study of Mesenchymal Stem Cells and Spinal Fusion
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.
Lumbar Spondylolisthesis Involving L4-L5, and/or
Degenerative Discopathy Involving L4-L5
Procedure: Standard treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||"Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease|
- 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) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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 (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
- Efficacy spinal fusion by imaging procedures (X-Ray). [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]Spinal fusion will be assessed by spinal X-Ray
- Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography.
- Clinical outcomes (VAS) [ Time Frame: 7 days and at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]Pain measurement by visual analogue scale (VAS)
- Clinical outcomes (SF-36) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36
- Clinical outcome (Oswestry Disability Index) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability Index
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue for spinal fusion
Isolation and "ex-vivo" expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, División de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion.
Sham Comparator: Standard treatment
Instrumented spinal fusion together with patient's bone iliac crest.
Procedure: Standard treatment
Instrumented spinal fusion together with patient's bone iliac crest
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552707
|Contact: Ruth Coll, MD||+34 93 557 3500 ext firstname.lastname@example.org|
|Contact: Joan Garcia, MD, PhD||+34 93 557 email@example.com|
|Hospital Universitari Germans Trias i Pujol||Recruiting|
|Badalona, Barcelona, Spain, 08916|
|Principal Investigator: Maite Ubierna, MD, PhD|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Principal Investigator: Alex del Arco, MD, PhD|
|Hospital Vall d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Principal Investigator: Joan Bagó, MD, PhD|
|Sub-Investigator: Ana García de Frutos, MD, PhD|
|Institut Universitari Dexeus (ICATME)||Recruiting|
|Barcelona, Spain, 08028|
|Principal Investigator: Enric Cáceres, MD, PhD|
|Parc de Salut Mar||Recruiting|
|Barcelona, Spain, 08003|
|Principal Investigator: Andreu Lladó, MD, PhD|
|Sub-Investigator: Guillem Saló, MD, PhD|
|Principal Investigator:||Joan Bagó, MD, PhD||Hospital Universitari Vall d'Hebron|