EUCTR2017-002092-25-IT进行中（未招募）1 期
A phase 2/3 prospective, multicentre randomized, double-blind trial, comparing intradiscal allogeneic adult BM-MSC therapy and sham-treated controls in subjects withchronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive toconventional therapy - Efficacy of intradiscal injection of BM-MSC in subjects with chronic LBP due to lumbar DDD unrespons
CENTRE HOSPIITALIIER UNIIVERSIITAIIRE DE MONTPELLIIER0 个研究点目标入组 112 人开始时间: 2021年6月17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 performed during at least 1 month before inclusion and pain medication
- •with level 2 analgesics in failure or intolerant to level during at least 1 month) 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:
- •o Oral corticosteroid therapy within the previous 3 months, OR
- •o Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3
- •-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, as well as lumbar
- •cysts and radiculopathy
- •-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
- •-Patients not eligible to the intravertebral disc surgery
- •-Patients who have the risk to undergo a surgery in the next 6 months
- •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.
- •-Pregnant or lactating women, or premenopausal women not using an acceptable form of
- •birth control, are ineligible for inclusion. Specific recommendations for contraception
- •and pregnancy testing is included in the information provided in the IB.Contraception
- •will be maintained during treatment and until the end of relevant systemic exposure.
- •Additional pregnancy testing will be performed at the end of relevant systemic
- •exposure.The patients will be required to use contraception for 2 years until the study
- •has completed.
- •-In each case of delayed menstrual period (over one month between menstruations)
- •confirmation of absence of pregnancy is strongly recommended. Methods that can achieve a
- •failure rate of less than 1% per year when used consistently and correctly are
- •considered as highly effective birth control methods. Such methods include:
- •combined (estrogen and progestogen containing) hormonal contraception associated with
- •inhibition of ovulation : oral, intravaginal, transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation : oral,
- •injectable, implantable; intrauterine device (IUD);
- •intrauterine hormone-releasing system ( IUS);
- •bilateral tubal occlusion; vasectomised partner
- •sexual abstinence are ineligible for inclusion.
- •-Positive serology for following infection: Syphilis, HIV, Hepatitis B, or C.
- •-Contraindication to MRI assessed by the investigator.
- •-Intolerance or allergy to local anaesthesia.
- •-Any history of Cancer or immunodeficiency disease.
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