A Prospective, Randomized, Double-Blinded, Vehicle- and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single-Level, Symptomatic Lumbar Intervertebral Disc Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- Efficacy (Pain)
研究概览
简要总结
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.
详细描述
This is a Phase I, first-in-human, randomized, double-blind, vehicle and placebo-controlled, parallel-group, multi-center study in subjects with single-level, symptomatic lumbar intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with two control groups (saline, Sodium Hyaluronate).
8 study visits will be completed by all subjects; screening, day 1 (injection day), week 4, week 12, week 26, week 52, week 72 and week 104. The subject will be assessed for safety and efficacy utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study will have a 1 year follow-up and a 1 year extension period (total 2 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must have:
- •Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-
- •Chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care.
- •Low-back pain of 40 to 90 mm on the VAS and ODI score of 30 to 90.
排除标准
- •The subject is excluded if he/she has:
- •Symptomatic involvement of more than one lumbar disc.
- •Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.
- •Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.
- •Evidence of dynamic instability on lumbar flexion-extension radiographs.
- •Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc.
- •Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology.
- •Clinical suspicion of facet pain as primary pain generator.
- •Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection.
- •Patients who are deemed unsuitable for clinical study participation by the investigator.
研究组 & 干预措施
High Dose IDCT
Single intradiscal injection with High Dose IDCT (9M cells).
干预措施: IDCT (Biological)
Low Dose IDCT
Single intradiscal injection with Low Dose IDCT (3M cells).
干预措施: IDCT (Biological)
Saline
Single intradiscal injection with saline solution.
干预措施: Saline Solution (Drug)
Sodium Hyaluronate Vehicle
Single intradiscal injection with Sodium Hyaluronate Vehicle.
干预措施: Sodium Hyaluronate (Drug)
结局指标
主要结局
Efficacy (Pain)
时间窗: 1 Year
Evaluate the effect of IDCT on pain as measured by a 0-100mm Visual Analogue Scale (VAS). 0: no pain, 100: worst pain imaginable.
Safety as measured by number of Adverse Events
时间窗: 2 Years
To evaluate the safety and tolerability of a single injection of IDCT in subjects with single-level, symptomatic early to moderate lumbar intervertebral disc degeneration as measured by the incidence of grade 2 or greater AEs and SAEs observed from Day 1 to week 104
次要结局
- Disability(2 Years)