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VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
Full description
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
Enrollment
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Inclusion criteria
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:
Failed conservative care over the past 6 months of at least 2 conservative treatments including:
An MRI demonstrating:
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
Exclusion criteria
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:
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)
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
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Central trial contact
Jasmine Wilson; Monica Unger
Data sourced from clinicaltrials.gov
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