A Pilot Study Evaluating the Safety and Clinical Effectiveness of Nucleus Pulposus Allograft for Supplementation of Nucleus Pulposus Tissue in Older Patients With Symptomatic Degenerated Discs
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 10
- 主要终点
- Review of all Adverse Events for Safety of treatment and product
研究概览
简要总结
VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
详细描述
The study will include adult subjects, ages 65 years and older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care.
Each subject will receive one injection per each affected level (max of 3 levels) and be evaluated for efficacy and safety during the 6 month observation period. The study is expected to be completed within 18 months, inclusive of enrollment and follow-up for all subjects.
Subjects will be evaluated at baseline and followed through 6 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 26 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Body mass index (BMI) ≤ 35
- •Documented diagnosis of moderate radiographic degeneration of up to 3 intervertebral discs from L1 to S1, with a suspected associated discogenic chronic low back pain
- •Chronic LBP for ≥ 6 months
- •Discogenic low back pain diagnosis based on:
- •History including low back pain aggravated with coughing, sneezing, and increase of abdominal pressure
- •Physical exam including pain with flexion (sitting or standing), and/or sitting intolerance
- •Failed conservative care over the past 6 months of at least 2 conservative treatments including:
- •oral pain medication (analgesics, steroids and/or non-steroidal anti-inflammatory drugs [NSAIDs]),
- •structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of low back pain
- •epidural steroid injections and/or facet injections/selective nerve blocks
- •An MRI demonstrating:
- •1 to 3 vertebral level involvement L1-S1
- •Modified Pfirrmann Grade 3-7
- •No Modic changes or if changes ≤ 2
- •Oswestry Disability Index (ODI) score at time of evaluation of ≥ 21 and ≤ 80 points
- •Low back pain of Baseline Numeric Rating Scale (NRS) score of ≥ 5 on the 11-point scale
- •No signs or symptoms of current infection
- •Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
- •Be 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;
- •Radicular pain greater than back pain by history within the past 8 weeks. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed;
- •Known allergies to Gentamicin or Vancomycin
- •Any of the following conditions at the index level:
- •Contained disc protrusion >5 mm or disc extrusion, or spondylolisthesis >5 mm (lysis and degenerative);
- •Seronegative spondyloarthropathy;
- •Symptomatic spinal stenosis (moderate to severe in degree);
- •Chronic facet syndrome;
- •Spondylodiscitis;
- •Bilateral spondylolysis;
- •Current or history of osteoporotic or tumor-related vertebral body compression fracture;
- •Previous lumbar spine fusion surgery or disc arthroplasty;
- •History of sacroiliac (SI) joint pain/injections during the past 1 months or SI joint fusion within the past six months;
- •Received chemonucleolysis or percutaneous treatment of the affected disc prior to the study;
- •History of lumbar epidural steroid injections within 4 weeks prior to study treatment;
- •Received any lumbar intradiscal treatment injection or procedure (e.g., injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty) and any nerve ablation procedures at the same or adjacent level (e.g., Basivertebral nerve ablation, dorsal ramus or sinovertebral nerve ablations). Discography and anesthetic discography may be performed but must be done at least 2 weeks or more prior to the injection procedure;
- •History of lumbar facet joint steroid injections within 4 weeks of procedure;
- •History of radiofrequency ablation within 8 weeks of procedure;
- •Been a recipient of prior stem cell/progenitor cell therapy or other biological intervention (e.g., PRP) to repair the target intervertebral disc;
- •Severe motor deficit or cauda equina disorder based on investigator determination;
- •Diagnosis of any traumatic neurological disorders;
- •Severe diseases of any other major body system as judged by the investigator, including malignant diseases of any solid organ or any hematologic malignancy during the previous 5 years;
- •Demonstrate 3 or more Waddell's signs of Inorganic Behavior;
- •Any mental instability, bipolar disorders, 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;
- •Compensated injuries or ongoing litigation regarding back pain/injury, or financial or other incentives to remain impaired;
- •Any medical condition that impairs follow-up (i.e., fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, reflex sympathetic dystrophy);
- •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; subjects on long-acting opioids may be given option to wean off opiates before enrollment. Subjects on short-acting opiates (e.g., hydrocodone, oxycodone, tramadol, etc.) may be included and utilization monitored after the treatment;
- •Are currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd is allowed, as well as inhalation steroids for asthma);
- •Non-MRI compatible devices and active implantable devices, such as spinal cord stimulators, intrathecal pumps, etc.
- •Bilateral spondylolysis at any level;
- •Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc(s)
结局指标
主要结局
Review of all Adverse Events for Safety of treatment and product
时间窗: baseline to 6 months
Evaluate the incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events from baseline through the final follow-up visit that are related to treatment and product
Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
时间窗: baseline to 3 months
Evaluate the change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability). The ODI is 10 categories of function to quantify disability due to low back pain.
Patient self-reporting of Pain
时间窗: baseline and 3 months
Changes in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 months measuring subjects meeting lower back pain NRS improvement.
次要结局
- Patient self-reporting of Pain in low back(3-6 months)
- Morphine Milligram Equivalents (MME) change(baseline, 1, 3 and 6 months)
- Patient self-reporting of Pain(3-6 months)
- PROMIS-29 change(baseline, 3 and 6 months)
- Neurological status change(baseline, 1, 3 and 6 months)
- Patient self-reporting of Function(3-6 months)
- Magnetic Resonance Imaging (MRI) review to determine disc health changes(baseline - 6 months)
- Oswestry Disability Index (ODI) score change(baseline and 6 months)
- Numeric Rating Scale change(baseline, and 6 months)