"Ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue for Spinal Fusion in Spine Degenerative Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 10
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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)
时间窗: 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)
时间窗: 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.
次要结局
- Efficacy spinal fusion by imaging procedures (X-Ray).(3, 6 and 12 months)
- Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography)(6 and 12 months)
- Clinical outcomes (VAS)(7 days and at 3, 6 and 12 months)
- Clinical outcome (Oswestry Disability Index)(3, 6 and 12 months)
- Clinical outcomes (SF-36)(3, 6 and 12 months)