Treatment of Lumbar Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV*) *MSV: Bone Marrow Mesenchymal Stromal Cells Expanded Using the Valladolid IBGM Procedure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pain and Disability Evaluation
研究概览
简要总结
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD). The trial is based in previous results with autologous MSC (Orozco et al., Transplantation 92: 822-828; 2011). Here we propose a phase I-II trial, prospective, randomized, blinded, and controlled for the treatment DDD using MSV, a Good Manufacturing Practice (GMP)-compliant expanded bone marrow MSC (MSV, Investigational medicinal product Num. 10-134). The assay consists of two arms with 12 patients each one. Patients in the experimental arm will be given a single intra-discal transplantation of MSV (25 millions in 2 ml). Control patients will be infiltrated in the paravertebral muscles close to the lesion with 2 ml of 1% mepivacain. We shall follow the evolution of pain, disability and quality of life as well as disc fluid content by Magnetic Resonance Imaging (T2-calibrated).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.
- •Fibrous ring capable of holding the cell implantation, demonstrated by Magnetic resonance imaging (MRI) image (stages 2, 3 and 4 of Adams).
- •Decrease of disc height of more than 20% (radiographic measurement in side image).
- •Absence of spinal infection.
- •Haematological and biochemical analysis wit no significant alterations that contraindicates intervention.
- •The patient is able to understand the nature of the study.
- •Informed written consent of the patient.
排除标准
- •Age over 75 or under 18 or legally dependent
- •Allergy to gentamicin, or to bovine, cattle or horse serum.
- •Congenital or acquired diseases leading to spine deformations that may upset cell application.
- •Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
- •Modic III changes on MRI images (31).
- •Overweight with body mass index (mass in Kg/size in m2) greater than 35 (obesity grade II).
- •Pregnancy or breast-feeding
- •Neoplasia
- •Immunosuppression
- •Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- •Other conditions that may, according to medical criteria, discourage participation in the study.
研究组 & 干预措施
Allogenic Mesenchymal Stromal Cells
Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intradiscal injection of 25 millions MSC in 2 ml of saline
干预措施: Allogenic Mesenchymal Stromal Cells (Biological)
Mepivacaine
Infiltration of paravertebral musculature close to the affected disc(s) with 2 ml of 1% Mepivacaine
干预措施: Mepivacaine (Drug)
结局指标
主要结局
Pain and Disability Evaluation
时间窗: Change since the baseline (before intervention) up to the end of the follow-up period, 12 months after the intervention
Change in the composite variable, which includes pain and disability 1 year after intervention, was plotted as a function of the initial pain score or disability index. Results for the relief of lumbar pain and Oswestry disability index were all included for both, control and cell-treated patients. The scores obtained from this analysis (slope of the plot) range from 0 to 1, with higher scores meaning a better outcome.
次要结局
- Oswestry Disability Index at 3 Months(At 3 months after the intervention)
- Oswestry Disability Index at 12 Months(At 12 months after the intervention)
- SF-12 Physical Component at 6 Months(6 months after the intervention)
- Evaluation of Affected Disc(s) by Quantitative MRI Ratio 12/6months(At 12 months from 6 months after the intervention)
- Visual Analogue Scale at 12 Months(At 12 months after the intervention)
- SF-12 Physical Component at 12 Months(12 months after the intervention)
- Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 12 Months(At 12 months after the intervention)
- SF-12 Physical Component at 3 Months(3 months after the intervention)
- Visual Analogue Scale at 3 Months(At 3 months after the intervention)
- Visual Analogue Scale at 6 Months(At 6 months after the intervention)
- Oswestry Disability Index at 6 Months(At 6 months after the intervention)
- SF-12 Mental Component at 3 Months(3 months after the intervention)
- SF-12 Mental Component at 6 Months(6 months after the intervention)
- Pfirrmann Stage at 12 Months(At 12 months after the intervention)
- Evaluation of Affected Disc(s) by Quantitative Magnetic Resonance Imaging (RMI): Density at 6 Months(At 6 months after the intervention)
- SF-12 Mental Component at 12 Months(12 months after the intervention)
- Pfirrmann Stage at 6 Months(At 6 months after the intervention)