EUCTR2012-004444-30-ES进行中（未招募）1 期
Treatment of degenerative disc disease with allogenic mesenchymal cells—MSV
Citospin0 个研究点开始时间: 2013年2月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Lumbar degenerative disc disease of one or two disks with predominant low back pain and / or sciatica persisting after conservative treatment (medical and physiotherapy) over 6 months.
- •2. Full annulus, capable of holding cell implantation, demonstrated in the MR image (stages 2, 3 and 4 of Adams) (Adams et al., 2000).
- •3. Decreased disc space height of more than 20% measured
- •radiographically in lateral view.
- •4. Absence of spinal infection.
- •5. Hematological and biochemical analysis without significant alterations that contraindicate surgery
- •6. The patient is able to understand the nature of the study.
- •7. Written informed consent of the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
- •1. Lumbar degenerative disc disease of one or two disks with predominant low back pain and / or sciatica persisting after conservative treatment (medical and physiotherapy) over 6 months.
- •2. Full annulus, capable of holding cell implantation, demonstrated in the MR image (stages 2, 3 and 4 of Adams) (Adams et al., 2000).
- •3. Decreased disc space height of more than 20% measured
- •radiographically in lateral view.
- •4. Absence of spinal infection.
- •5. Hematological and biochemical analysis without significant alterations that contraindicate surgery
- •6. The patient is able to understand the nature of the study.
- •7. Written informed consent of the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
- •1. Lumbar degenerative disc disease of one or two disks with predominant low back pain and / or sciatica persisting after conservative treatment (medical and physiotherapy) over 6 months.
- •2. Full annulus, capable of holding cell implantation, demonstrated in the MR image (stages 2, 3 and 4 of Adams) (Adams et al., 2000).
- •3. Decreased disc space height of more than 20% measured
- •radiographically in lateral view.
- •4. Absence of spinal infection.
- •5. Hematological and biochemical analysis without significant alterations that contraindicate surgery
- •6. The patient is able to understand the nature of the study.
- •7. Written informed consent of the patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age under 18 or over 75 or legally dependent
- •2. Allergies gentamicin or bovine sera, bovine or equine.
- •3. Congenital or acquired deformities of the spine significant obstacles to the application.
- •4. Pathology conditional spinal segmental instability, spinal canal stenosis, isthmus pathology and other disturbances that might compromise the study at the discretion of the investigators
- •5. Presence of Modic changes III in MRI images (Modic & Ross, 2007)
- •6. Excess weight with body mass index (BMI) greater than 35
- •7. Pregnancy or breastfeeding
- •8. neoplastic disease
- •9. Immunosupresive situation.
- •10. Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- •11. Any other condition or circumstance that would compromise participation in the study medically
- •1. Age under 18 or over 75 or legally dependent
- •2. Allergies gentamicin or bovine sera, bovine or equine.
- •3. Congenital or acquired deformities of the spine significant obstacles to the application.
- •4. Pathology conditional spinal segmental instability, spinal canal stenosis, isthmus pathology and other disturbances that might compromise the study at the discretion of the investigators
- •5. Presence of Modic changes III in MRI images (Modic & Ross, 2007)
- •6. Excess weight with body mass index (BMI) greater than 35
- •7. Pregnancy or breastfeeding
- •8. neoplastic disease
- •9. Immunosupresive situation.
- •10. Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- •11. Any other condition or circumstance that would compromise participation in the study medically
- •1. Age under 18 or over 75 or legally dependent
- •2. Allergies gentamicin or bovine sera, bovine or equine.
- •3. Congenital or acquired deformities of the spine significant obstacles to the application.
- •4. Pathology conditional spinal segmental instability, spinal canal stenosis, isthmus pathology and other disturbances that might compromise the study at the discretion of the investigators
- •5. Presence of Modic changes III in MRI images (Modic & Ross, 2007)
- •6. Excess weight with body mass index (BMI) greater than 35
- •7. Pregnancy or breastfeeding
- •8. neoplastic disease
- •9. Immunosupresive situation.
- •10. Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- •11. Any other condition or circumstance that would compromise participation in the study medically
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