Clinical trial NCT05201287: VIA Disc NP Pilot for Patients With Symptomatic Degenerated Discs
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Low Back Pain
Disc Degeneration
Keywords: low back pain
degenerative disc disease
Lead sponsor: VIVEX Biologics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2022-01-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Up to 35 patients at 7 sites will receive treatment.
Primary purpose: TREATMENT

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.

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.

1. Age 18 years or older;
2. Body mass index (BMI) \< 35;
3. 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;
4. Chronic LBP for ≥ 6 months;
5. Failed conservative care over the past 3 months of at least 2 conservative treatments including:

   1. oral pain medication \[analgesics, steroids and/or non-steroidal anti-inflammatory drugs (NSAIDs)\],
   2. structured physical therapy or exercise program prescribed by physical therapist, chiropractor, provider or physician specifically for the treatment of low back pain, and
   3. epidural steroid injections and/or facet injections/selective nerve blocks;
6. An MRI demonstrating:

   1. 1 to 2 vertebral level involvement L1-S1;
   2. Modified Pfirrmann Grade 3-7;
   3. No modic changes or if changes ≤ 2;
7. Oswestry Disability Index (ODI) score at time of evaluation of ≥ 40 and ≤ 80 points;
8. Low back pain of Baseline Numeric Rating Scale (NRS) score of ≥ 6 on the 11-point scale;
9. No signs or symptoms of current infection;
10. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study;
11. 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:

1. Known allergies to Gentamicin, Vancomycin;
2. Contraindications to the proposed sedation/anesthetic protocol;
3. 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;
4. Any of the following conditions at the index level:

   1. Contained disc protrusion \>5 mm or disc extrusion, or spondylolisthesis \>5 mm (lysis and degenerative);
   2. Seronegative spondyloarthropathy;
   3. Symptomatic spinal stenosis (moderate to severe in degree);
   4. Chronic facet syndrome;
   5. Spondylodiscitis;
   6. Bilateral spondylolysis;
   7. Current or history of osteoporotic or tumor-related vertebral body compression fracture;
   8. Previous lumbar spine fusion surgery or disc arthroplasty;
5. History of sacroiliac (SI) joint pain/injections during the past 3 months or SI joint fusion within the past two years;
6. Received chemonucleolysis or percutaneous treatment of the affected disc prior to the study;
7. History of epidural steroid injections within 1 week prior to study treatment;
8. 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 anaesthetic discography may be performed but must be done at least 2 weeks or more prior to the injection procedure;
9. Been a recipient of prior stem cell/progenitor cell therapy or other biological intervention (e.g., PRP) to repair the target intervertebral disc;
10. Severe motor deficit or cauda equina disorder based on investigator determination;
11. Diagnosis of any traumatic neurological disorders;
12. 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;
13. Demonstrate 3 or more Waddell's signs of Inorganic Behavior;
14. 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;
15. Compensated injuries or ongoing litigation regarding back pain/injury, or financial or other incentives to remain impaired;
16. If female and of child-bearing potential, are pregnant or breastfeeding or a plan to become pregnant or breastfeed in the first 12 months post-treatment;
17. Any medical condition that impairs follow-up (i.e., fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, reflex sympathetic dystrophy);
18. 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;
19. 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);
20. Active implantable devices, such as cardiac pacemakers, spinal cord stimulators, intrathecal pumps, etc.
21. Bilateral spondylolysis at any level;
22. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.

Primary outcomes:
measure: Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
timeFrame: baseline to 3 months
measure: Review of all Adverse Events for Safety of treatment and product
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Patient self-reporting of Function
timeFrame: 3-6 months
measure: Patient self-reporting of Pain
timeFrame: 3-6 months
measure: Patient self-reporting of Pain in low back
timeFrame: 3-6 months
measure: Oswestry Disability Index (ODI) score change
timeFrame: baseline and 6 months
measure: Numeric Rating Scale change
timeFrame: baseline, 3 and 6 months
measure: Neurological status change
timeFrame: baseline to 6 months
measure: Return to work
timeFrame: baseline - 6 months
measure: Magnetic Resonance Imaging (MRI) review to determine disc health changes
timeFrame: baseline-6 months
Other outcomes:
Locations:
city: Larkspur
country: United States
facility: California Orthopedics and Spine
state: California
city: Santa Monica
country: United States
facility: Source Health
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Edmond
country: United States
facility: Clinical Investigations, LLC
state: Oklahoma
city: Richmond
country: United States
facility: Virginia iSpine
state: Virginia
Study officials:
affiliation: Clinical Radiology of Oklahoma
name: Douglas Beall, MD
role: PRINCIPAL_INVESTIGATOR
References: