Via Disc Nucleus Pulposus Older Patients Pilot

Study Overview
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Brief Summary
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VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

Detailed Description
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The study will include adult subjects, ages 65-80 years old, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care. Each subject will receive one injection per level 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

Official Title
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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

Conditions
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Degenerative Disc Disease, Low Back Pain, Disc Degeneration

Intervention / Treatment
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* Other: VIA Disc Nucleus Pulposus Allograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 years to 80 years old; 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: a. History including i. Low back pain aggravated with coughing, sneezing, and increase of abdominal pressure b. Physical exam i. Pain with flexion (sitting or standing) ii. 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, and 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. 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; 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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Up to 35 patients at up to 10 sites will receive treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VIA Disc NP<br>HCT/P: VIA Disc Nucleus Pulposus Allograft | Other: VIA Disc Nucleus Pulposus Allograft<br>* A single dose, intradiscal injection of 100mg of VIA Disc NP mixed with 2ml sterile saline administered to the affected 1 to 3 levels, L1-S1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI) | 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. | baseline to 3 months | 
| Review of all Adverse Events for Safety of treatment and product | 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 | baseline to 6 months | 
| Patient self-reporting of Pain | 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. | baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reporting of Function | Oswestry Disability Index (ODI) is measured 0 (minimal disability) to 100 (maximal disability). This index is comprised of ten categories of function to quantify disability due to low back pain. Functional responder analysis at 3 and 6 months measured as subjects meeting functional improvement of ≥ 10, 15 and 20 points in ODI scores. | 3-6 months | 
| Patient self-reporting of Pain | 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 and 6 months measured as subjects meeting lower back pain NRS improvement of 50%. | 3-6 months | 
| Patient self-reporting of Pain in low back | Changes in Numeric Rating Scale (NRS) scores. Eleven-point pain scale used for patient to self-report level of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 and 6 months measured as subjects meeting lower back pain NRS improvement of ≥30%. | 3-6 months | 
| Oswestry Disability Index (ODI) score change | Change from baseline in ODI scores at 6 months. Ten category index comprising of function to quantify due to low back pain. ODI is measured 0 (minimal disability) to 100 (maximal disability). | baseline and 6 months | 
| Numeric Rating Scale change | Changes from baseline in Numeric Rating Scale (NRS) score at 3 and 6 months. Eleven-point pain scale used for patient self-reporting of pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). | baseline, 3 and 6 months | 
| Neurological status change | Change from baseline in motor function (graded 0 - no movement to 4 - active movement against resistance), reflexes (0 - absence to 4 - abnormal/hyperactive) and sensory status (graded normal or abnormal) based on physician's physical exam at 1, 3, and 6 months. | baseline, 1, 3 and 6 months | 
| Magnetic Resonance Imaging (MRI) review to determine disc health changes | Magnetic Resonance Imaging (MRI) taken at baseline compared to 6 months reviewing changes in treated disc levels (disc height, volume hydration of disc and Modified Pfirrman grade) | baseline - 6 months | 
| Morphine Milligram Equivalents (MME) change | Changes from baseline in morphine milligram equivalents use at 3 and 6 months. | baseline, 1, 3 and 6 months | 
| PROMIS-29 change | Change from baseline in pain intensity at 3 and 6 months. Questionnaire with 29 questions using a since 0-10 numeric rating item and sevel health domains (physical function, pain interference, fatigue depressive symptoms, anxiety, ability to participate in activities and sleep) utilizing four questions per domain. | baseline, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, degenerative disc disease