EUCTR2017-002092-25-ES进行中（未招募）1 期
A phase 2/3 prospective, multicentre randomized, double-blind trial, comparing intra-discal allogeneic adult BM-MSC therapy and sham-treated controls in subjects with chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy
niversity Hospital of Montpellier0 个研究点目标入组 112 人开始时间: 2018年5月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
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
- •- Age between 18 and 60 years.
- •- Symptomatic chronic low back pain unresponsive to conservative therapy (including physical therapy) for at least 3 months.
- •- DDD assessed by (Pfirrmann’s score modified Griffith et al) grade 4 to 7 at one level. If second level, it should be adjacent (Pfirrmann’s score 1-4 maximum)
- •- Low back Pain baseline > 40 mm on VAS (0-100).
- •- NSAID washout of at least 2 days before screening
- •- Painkillers washout of at least 24 hours before screening
- •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 112
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralization and hemisacralization).
- •- Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome on Xray or MRI (osteophyte and facet hypertrophy).
- •- Prior to the screening visit, has received:
- •oOral corticosteroid therapy within the previous 3 months, OR
- •oIntramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months
- •?Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion with antero-post translation > 3 mm and/or angular mobility > 15°).
- •?Spinal canal stenosis (Schizas score > B).
- •?History of spinal infection.
- •?Lumbar disc herniation with non truncated sciatica or cruralgia.
- •?Previous discal puncture or previous spine surgery.
- •?DDD on 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases
- •?Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II).
- •?Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
- •- Abnormal blood tests: hepatic (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >1.5 × upper limit of normal [ULN]), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of <100 × 109/L.
- •- Significant medical problems, such as uncontrolled hypertension, symptomatic heart failure; or any other clinically relevant condition or current medication that in the opinion of the investigator contra-indicates the use of any of the study or rescue medications.
- •- Positive serology for following viral infection: HIV, Hepatitis B, or Hepatitis C.
- •- Contraindication to MRI assessed by the investigator.
- •- Intolerance or allergy to local anaesthesia.
- •- Any history of Cancer or immunodeficiency disease.
- •- Previous transfusion or transplantation.
研究者
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