EUCTR2019-004476-19-IT进行中（未招募）1 期
Autologous mesenchymal stem/stromal Cells for the Treatment of workers affected by chronic low back pain due to multilevel InterVErtebral disc degeneration: a phase IIB randomized clinical trial - ACTIVE - ACTIVE
IVERSITÀ CAMPUS BIO-MEDICO DI ROMA0 个研究点目标入组 52 人开始时间: 2021年1月26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
- 52
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
- •- Workers ( it means subject has worked at least 2 months, even if not continuously, in the last 6 months)
- •- Age between 18 and 65 years.
- •- Signed informed consent.
- •- Symptomatic chronic LBP due to moderate-severe IDD [modified Pfirrmann score 3-5 (Pfirrmann et al., 2001), Griffith score 4-8 (Griffith et al., 2007)] at max. 4 levels of the lumbar spine unresponsive to
- •conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments include NSAIDs, paracetamol, opioids and myorelaxant.
- •- Annulus fibrosus intact, demonstrated by MRI.
- •- Pain baseline > 40 mm on VAS (0- 100).
- •- NSAIDs washout of at least 2 days before screening.
- •- Painkillers washout of at least 24 hours before screening.
- •- For females of childbearing potential (see definitions in paragraph 6.5), a negative pregnancy test must be documented at Screening.
- •- Men and women should use effective contraception during treatment and for at least 24 months after BM-MSC discontinuation. The complete list of contraceptive methods is described in the patient information sheet and in paragraph 6.5. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.
- •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 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •- Non-workers (it means that the person has worked less than 2 months, although not continuously, in the last 6 months)
- •- Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenetative spondilolisthesis, previous fractures of the lumbar spine).
- •- Spinal segmental instability assessed by dynamic X-Ray.
- •- Symptomatic facet joints syndrome on MRI (facet joints iperintensity and ipertrophy evaluated at coronal T2 weighted MRI).
- •- Prior to the screening visit, has received:
- •.Oral corticosteroid therapy within the previous 3 months, OR
- •.Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months.
- •- Spinal canal stenosis (Schizas score > B).
- •- History of spinal infection.
- •- Lumbar disc herniation and sciatica.
- •- Endplate abnormality such as Schmorl’s Nodes.
- •- Previous discal puncture or previous spine surgery.
- •- IDD with Modic IIII changes on MRI images.
- •- Patients not eligible to the intravertebral disc surgery.
- •- Patients who have the risk to undergo a surgery in the next 6 months.
- •- Patients with local infusion device/devices for corticosteroids.
- •- 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.
- •- Pregnant or lactating women, or premenopausal women not using an acceptable form of birth control, are ineligible for inclusion. 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 from initial treatment administration until 24 months after the last dose of study drug.
- •- In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended. The complete list of contraceptive methods is described in the patient information sheet and in paragraph 6.5.
- •- 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.
- •- Previous transplantation.
研究者
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