Randomized, Sham-Controlled, Multi-Center, Double-Blind Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft to Supplement Nucleus Pulposus Tissue in Participants With Lumbar Discogenic Pain Associated With Degenerative Disc Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 325
- 试验地点
- 21
- 主要终点
- Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months.
研究概览
简要总结
VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs.
This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 to 85 years old
- •Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
- •Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
- •Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
- •ODI score of ≥ 40 to ≤ 80
- •Positive sustained hip flexion test
- •Intolerance to prolonged sitting
- •Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
- •Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of > 2 years
排除标准
- •Contraindications to the proposed sedation/anesthetic protocol
- •Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater
- •Symptomatic vertebral compression fracture
- •Previous surgical treatment of the lumbar spine
- •History of sacroiliac (SI) joint fusion within the past six months
- •Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, SI joint pain injection, injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure
- •Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)
- •Received prior intradiscal stem cell/progenitor cell therapy or other biological intervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0 procedure
- •Evidence of dynamic instability on lumbar flexion-extension radiographs (>3 mm) at any level
- •Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes adjacent to the target disc
- •Radiographic evidence of a full thickness annular tear at the target disc or other abnormal disc morphology
- •Clinical suspicion of facet pain as primary pain generator
- •A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, recent history of myocardial infarction, uncontrolled diabetes (>7.0% HbA1C), etc.)
- •Received VIA Disc NP previously.
- •Deemed unsuitable for clinical study participation by the Investigator
- •Evidence of substance abuse (including marijuana); note: subjects using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within the 3 months prior to screening and subjects on long-acting opioids may be given option to wean off opiates before enrollment; participants on short-acting opiates (e.g., hydrocodone, oxycodone, tramadol, etc.) may be included and utilization monitored after the treatment
- •Opioid use of more than 90 MME/day
- •Currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd, or inhalation steroids for asthma is allowed)
- •Metal or ceramic implants in the lumbar spine region
- •Contraindications to MRI, including non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.
- •Involved in ongoing or closed (within 6 months of screening visit) litigation related to their back pain condition
- •Any mental instability, unstable bipolar disorders, unmanaged post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression and/or require new or changed anti-depressants or anti-psychotic medications within 3 months of enrollment
- •Diagnosis of any traumatic neurological disorders that may impact the study as per the judgement of the Investigator
- •Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study; pregnancy is confirmed by:
- •a positive pregnancy test during the screening visit
- •self-reported pregnancy
- •Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)
- •Received any experimental drug or device to treat the same condition used within 6 months prior to the screening visit or during the course of the clinical trial
- •Other persistent pain/nerve issues including, for example, radiculopathy, cauda equine syndrome, etc.
研究组 & 干预措施
VIA Disc NP
A single dose, intradiscal delivery of 100mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered at up to two affected levels, L1-S1.
干预措施: VIA Disc NP (Other)
Sham
The procedure will be identical to the investigational procedure with the following exception: A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. No saline or VIA Disc NP will be injected.
干预措施: Sham (Other)
结局指标
主要结局
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months.
时间窗: Baseline to 12 Months
The primary efficacy endpoint is the proportion of participants who achieve a minimal clinically important difference (MCID), defined as at least a 30% reduction in back pain VAS score from baseline to 12 months, in the VIA Disc NP group compared to that in the sham-control group.
Primary Safety Endpoint - Proportion of participants reporting treatment-related AEs at 12 months.
时间窗: Baseline to 12 Months
The primary safety endpoint will be the proportion of participants that experience one or more treatment-related (Investigational Product (IP) or procedure), adverse events (AE) in the VIA Disc NP group compared to the sham-control group at 12 months.
次要结局
未报告次要终点