2024-519112-14-00招募中2 期
Intervertebral Disc REgeneration mediated by Autologous Mesenchymal stem/stromal cells intradiscal injection: a phase IIB randomized clinical trial
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年2月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of intradiscal injection of autologous BM-MSC using the visual analog scale (VAS) and functional status assessed by the Oswestry disability index (ODI) after 12 months of treatment, defining responders in case of at least 30% improvement in VAS or ODI at month 12 compared to baseline.
研究概览
简要总结
Evaluate the effectiveness of intradiscal injection of autologous BM-MSCs in reducing chronic LBP due to multilevel (max. 3 levels) lumbar IDD after 12 months of treatment in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36)
研究设计
- 分配方式
- Randomized
- 主要目的
- Dream Is A Phase 2 B Efficacy Monocenter, Prospective, Randomized, Controlled Double Blinded Tria
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Signed informed consent
- •Symptomatic chronic LBP due to moderate IDD [modified Pfirrmann score 3-4 (Pfirrmann et al., 2001), Griffith score 3-7(Griffith et al., 2007)] at max.3 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes NSAID, paracetamol, opioids and myorelaxant.
- •Annulus fibrosus intact, demonstrated by MRI
- •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
- •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 the paragraph 6.
- •As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.
排除标准
- •Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenetative spondilolisthesis
- •Endplate abnormality such as Schmorl’s Nodes
- •Previous discal puncture or previous spine surgery.
- •IDD with Modic III 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.
- •Spinal segmental instability assessed by dynamic X-Ray
- •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 the paragraph 6.
- •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.
- •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 1 month, OR
- •Intramuscular, intravenous or epidural corticosteroid therapy within the previous 1 month.Presence of a 4th level with symptomatic IDD (modified Pfirrmann score 3- 4, Griffith score 3-7) in the lumbar spine
- •Presence of a 4th level with symptomatic IDD (modified Pfirrmann score 3-4, Griffith score 3-7) in the lumbar spine.
- •Spinal canal stenosis (Schizas score > B).
- •History of spinal infection
- •Lumbar disc herniation and sciatica
结局指标
主要结局
To evaluate the efficacy of intradiscal injection of autologous BM-MSC using the visual analog scale (VAS) and functional status assessed by the Oswestry disability index (ODI) after 12 months of treatment, defining responders in case of at least 30% improvement in VAS or ODI at month 12 compared to baseline.
To evaluate the efficacy of intradiscal injection of autologous BM-MSC using the visual analog scale (VAS) and functional status assessed by the Oswestry disability index (ODI) after 12 months of treatment, defining responders in case of at least 30% improvement in VAS or ODI at month 12 compared to baseline.
次要结局
- To evaluate changes of the treated IVD induced by regenerative therapy by quantitative Magnetic Resonance Imaging (MRI) signal measurements in T2 between baseline and 1, 3, 6 and 12 months
- To evaluate modification of disability (ODI) and pain relief (VAS) considered as continuos measures, between baseline and 1, 3 and 6 months. • To evaluate modification of quality of life (SF-36 scores) and work ability index (WAI) considered as continuos measures, between baseline and 1, 3, 6 and 12 months.
- Safety and tolerability will be evaluated by recording adverse events (AEs) and serious AEs (SAEs) throughout the study till 12 months. Number of participants with adverse events, the correlation of the AE to the IMP and their severity will be used as a measure of safety and tolerability
- To evaluate consumption of medications to relieve pain such as type and dose of analgesics will be evaluated. Paracetamol (acetaminophen) and levels 2 analgesics will be assessed throughout the study at each visit
研究者
Gianluca Vadalà
Scientific
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
研究点 (1)
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