VIA Disc NP Pilot for Patients With Symptomatic Degenerated Discs

NCT05201287 | Active Not Recruiting

• 1 other identifier: VIA-2021-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Degenerative Disc Disease; Low Back Pain; Disc Degeneration

Keywords

low back pain; degenerative disc disease

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Patient self-reporting of Function

  3-6 months

• Patient self-reporting of Pain

  3-6 months

• Patient self-reporting of Pain in low back

  3-6 months

• Oswestry Disability Index (ODI) score change

  baseline and 6 months

• Numeric Rating Scale change

  baseline, 3 and 6 months

Study Arms (1)

VIA Disc Nucleus Pulposus Allograft

EXPERIMENTAL

A single dose, intradiscal injection of 100mg of VIA Disc NP mixed with 2ml sterile saline administered to the affected 1 or 2 levels, L1-S1.

Other: VIA Disc NP

Interventions

VIA Disc NP OTHER

VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.

Also known as: VIA Disc Nucleus Pulposus Allograft

VIA Disc Nucleus Pulposus Allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;

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;

Sponsors & Collaborators

• VIVEX Biologics, Inc.: lead
• MCRA: collaborator

Study Sites (6)

California Orthopedics and Spine

Larkspur, California, 94939, United States

Location

Source Health

Santa Monica, California, 90404, United States

Location

IPM Medical Group

Walnut Creek, California, 94598, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Clinical Investigations, LLC

Edmond, Oklahoma, 73013, United States

Location

Virginia iSpine

Richmond, Virginia, 23235, United States

Location

Related Publications (1)

• Beall DP, Davis TT, Amirdelfan K, Naidu RK, DePalma MJ, Costandi S, Yoon ES, Fleming JW, Block JE, Mekhail N. Supplemental nucleus pulposus allograft in patients with lumbar discogenic pain: results of a prospective feasibility study. BMC Musculoskelet Disord. 2025 May 1;26(1):437. doi: 10.1186/s12891-025-08701-0.

  PMID: 40312677 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas Beall, MD

  Clinical Radiology of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to 35 patients at 7 sites will receive treatment.

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: January 21, 2022
• Study Start: December 30, 2021
• Primary Completion: January 5, 2023
• Study Completion: December 27, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)