Degenerative Discopathy Involving L4-L5, Lumbar Spondylolisthesis Involving L4-L5, and/or
Conditions
Keywords
Spondylolisthesis, Degenerative discopathy, Mesenchymal Stem Cells, Bone marrow, Tissue engineering, Spinal fusion
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALXCEL-MT-OSTEO-ALPHA
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.
PROCEDUREStandard treatment
Instrumented spinal fusion together with patient's bone iliac crest
Sponsors
TFS Trial Form Support
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ministerio de Ciencia e Innovación, Spain
Banc de Sang i Teixits
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* L4-L5 degenerative spondylolisthesis grade I-II Meyerding isolated or associated to more than one level, and/or L4-L5 degenerative discopathy isolated or associated to more than one level. * 18 to 85 years of age (male and female) * Informed Consent Form signed * The patient is able to understand the nature of the study
Exclusion criteria
* Previous spine surgery * L4 isthmic spondylolisthesis * Smoker (more than 10 cigarettes a day) * Systemic or local infection * Patients treated with steroids (oral or systemic) within 3 months of entering the study, or treated with biphosphonates for more than 10 years * Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis. * Pregnant woman or intended to become pregnant, or breath feeding * Neoplasia within the previous 5 years, or without remission * Immunosuppressive states (except diabetes mellitus. Treatment with therapies is allowed) * Significant abnormal laboratory tests that contraindicates the surgery. * Participation in another clinical trial or treated with an investigational medicinal product the previous 3 months * Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria * The patient does not accept to be followed-up for a period that could exceed the clinical trial length * The patient is legally dependent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 (composed by ex-vivo expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes (VAS) | 7 days and at 3, 6 and 12 months | Pain measurement by visual analogue scale (VAS) |
| Efficacy spinal fusion by imaging procedures (X-Ray). | 3, 6 and 12 months | Spinal fusion will be assessed by spinal X-Ray |
| Clinical outcome (Oswestry Disability Index) | 3, 6 and 12 months | To assess the extent by which a person's functional level is restricted by disability by the Oswestry Disability Index |
| Clinical outcomes (SF-36) | 3, 6 and 12 months | This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36 |
| Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography) | 6 and 12 months | Spinal fusion will be assessed by the presence of solid bonny bridges using computerized helicoidal tomography. |
Countries
Spain
Outcome results
None listed