VIA Disc NP Pilot for Patients With Symptomatic Degenerated Discs

Status unconfirmed · Not applicable

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

In brief

VIA Disc NP is an allograft intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

Key facts

Study ID

NCT05201287

Run by

VIVEX Biologics, Inc.

People needed

35

Starts

2021-12-30

Expected to finish

2024-12-27

Last updated by the study team

2024-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 1 to 2 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 ≥ 40 and ≤ 80 points;
• Low back pain of Baseline Numeric Rating Scale (NRS) score of ≥ 6 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…

• 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;
• 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 3 months or SI joint fusion within the past two years;
• Received chemonucleolysis or percutaneous treatment of the affected disc prior to the study;
• History of epidural steroid injections within 1 week 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 anaesthetic discography may be performed but must be done at least 2 weeks or more prior to the injection 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;
• 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;
• Any medical condition that impairs follow-up (i.e., fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, reflex sympathetic dystrophy);

Where it is running

• California Orthopedics and Spine — Larkspur, California, United States
• Source Health — Santa Monica, California, United States
• IPM Medical Group — Walnut Creek, California, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Clinical Investigations, LLC — Edmond, Oklahoma, United States
• Virginia iSpine — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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