A Pilot Study Evaluating the Safety and Clinical Effectiveness of Nucleus Pulposus Allograft for Supplementation of Nucleus Pulposus Tissue in Patients With Symptomatic Degenerated Discs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- VIVEX Biologics, Inc.
- Enrollment
- 35
- Locations
- 6
- Primary Endpoint
- Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
VIA Disc NP is an allograft intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
Detailed Description
The study will include adult subjects, ages 18 years or older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care. For the purpose of the primary analysis, subjects are considered enrolled in the study once they have signed the informed consent. Each subject will receive one injection per level (max of 2 levels) and be evaluated for efficacy and safety during the up to 24 month observation period. The study is expected to be completed within 26 months, inclusive of enrollment and follow-up for all subjects. Subjects will be evaluated at baseline and followed through up to 24 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 104 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligibility for inclusion is evaluated on a site-specific basis based on each subject's medical, clinical, and radiographic presentation. In addition, for study consistency purposes, the MRI imaging will be submitted to Medical Metrics Imaging (MMI), a core lab, for independent review. MMI will review imaging of every subject to confirm radiographic inclusion criteria. The Medical Monitor will make the final determination for inclusion on all subjects based on review of the MRI relevant medical history and source documents.
- •Age 18 years or older;
- •Body mass index (BMI) \< 35;
- •Documented diagnosis of moderate radiographic degeneration of up to 2 intervertebral discs from L1 to S1, with a suspected associated discogenic chronic low back pain;
- •Chronic LBP for ≥ 6 months;
- •Failed conservative care over the past 3 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, and
- •epidural steroid injections and/or facet injections/selective nerve blocks;
- •An MRI demonstrating:
Exclusion Criteria
- •Known allergies to Gentamicin, Vancomycin;
- •Contraindications to the proposed sedation/anesthetic protocol;
- •Radicular pain greater than back pain by history or evidence of radicular pain or neurological deficit within the past 6 months. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed;
- •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;
Outcomes
Primary Outcomes
Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
Time Frame: 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.
Review of all Adverse Events for Safety of treatment and product
Time Frame: 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.
Secondary Outcomes
- Oswestry Disability Index (ODI) score change(baseline and 6 months)
- Patient self-reporting of Pain(3-6 months)
- Patient self-reporting of Pain in low back(3-6 months)
- Numeric Rating Scale change(baseline, 3 and 6 months)
- Patient self-reporting of Function(3-6 months)
- Neurological status change(baseline to 6 months)
- Return to work(baseline - 6 months)
- Magnetic Resonance Imaging (MRI) review to determine disc health changes(baseline-6 months)