NCT06325566进行中（未招募）3 期
A Prospective, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Combined With HA in Subjects With Moderate to Severe Chronic Low Back Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 41
- 主要终点
- Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with moderate to severe low back pain for a duration of at least six months who have failed at least 3 months of conservative care.
- •Participants who have moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a single disc suspected of causing chronic lower back pain (CLBP).
排除标准
- •Participants who have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the index intervertebral disc.
- •Participants with low back pain duration of less than 6 months or greater than 60 months.
- •Participants who have not received at least 3 months of conservative treatment for back pain without adequate pain relief.
- •Participants taking systemic immunosuppressants.
- •Participants with osteoporosis.
- •Participants with alcohol or substance abuse problems.
- •Participants with severe depression or anxiety.
- •Participants with cauda equina syndrome; fibromyalgia, symptomatic central vertebral canal stenosis, lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
- •Participants having undergone a surgical procedure affecting the structure/biomechanics of the disc (e.g., discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion, laminectomy, etc.) at the index or adjacent levels.
- •Participants who have received any lumbar intradiscal injection into the index disc or adjacent discs within three months prior to the start of screening, other than injection of contrast medium for discography.
- •Participants who received an epidural steroid injection within 6 weeks prior to informed consent.
- •Participants with evidence of neurologic deficit on any component of the lumbar neurological exam at baseline.
- •Participants with sacroiliac (SI) joint pain, as determined by a targeted physical exam, or SI joint injection.
- •Participants with facet joint pain, as determined by a medial branch block.
- •Participants with more than a single painful level.
- •Participants with a full thickness annular tear observed on magnetic resonance imaging (MRI) or discography.
- •Participants with low back pain that is less than moderate in severity.
- •Participants with extreme low back pain.
- •Participants who lack moderate to extreme functional limitations/disability.
- •Note: Other exclusion criteria may apply.
研究组 & 干预措施
Rexlemestrocel-L + HA
Experimental
Participants will receive rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0.
干预措施: Rexlemestrocel-L + HA mixture (Drug)
Control Group
Sham Comparator
Participants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0.
干预措施: Saline (Drug)
结局指标
主要结局
Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score
时间窗: Baseline and Month 12
Low back pain intensity will be measured using a VAS ranging from 0-100 millimeter (mm). A score of 0 represents no pain and 100 represents worst possible pain.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to Month 24
次要结局
- Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment(Baseline and Month 12)
- Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment(Baseline and Month 12)
- Percentage of Minimal Pain Responders at 12 Months Post-treatment(Month 12)
- Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment(Month 12)
- Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment(Month 24)
- Percentage of 30% VAS Pain Responders at 12 Months Post-treatment(Month 12)
研究者
研究点 (41)
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