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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Disc Disease
- Sponsor
- VIVEX Biologics, Inc.
- Enrollment
- 21
- Locations
- 5
- Primary Endpoint
- Review of all Adverse Events for Safety of treatment and product
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
Detailed 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
Investigators
Eligibility Criteria
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:
- •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
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:
- •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
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
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.
Patient self-reporting of Pain
Time Frame: 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.
Secondary Outcomes
- 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)