VIA Disc Nucleus Pulposus Older Patients Pilot

Status unconfirmed · Not applicable

Conditions studied: Degenerative Disc Disease, Low Back Pain, Disc Degeneration

In brief

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

Key facts

Study ID

NCT05412277

Run by

VIVEX Biologics, Inc.

People needed

21

Starts

2022-10-17

Expected to finish

2024-12-31

Last updated by the study team

2024-04-29

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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;

Where it is running

• Florida Spine & Pain Specialists — Tampa, Florida, United States
• Southern Pain and Spine Associates — Newnan, Georgia, United States
• Paradigm Spine Care & Interventional Pain — Slidell, Louisiana, United States
• Center for Clinical Research — Winston-Salem, North Carolina, United States
• Precision Spine Care — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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