Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease

NCT06778447 | Recruiting

• 1 other identifier: VIA-2024-002
• Study Type: interventional
• Target: 496
• Locations: 1 country
• Sites: 19

Brief Summary

VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.

Conditions

Degenerative Disc Disease; Disc Degeneration; Lumbar Discogenic Pain

Keywords

Degenerative Disc Disease; Lumbar Discogenic Pain

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months.

  The primary efficacy endpoint is the proportion of participants who achieve a minimal clinically important difference (MCID), defined as at least a 30% reduction in back pain VAS score from baseline to 12 months, in the VIA Disc NP group compared to that in the sham-control group.

  Baseline to 12 Months

• Primary Safety Endpoint - Proportion of participants reporting treatment-related AEs at 12 months.

  The primary safety endpoint will be the proportion of participants that experience one or more treatment-related (Investigational Product (IP) or procedure), adverse events (AE) in the VIA Disc NP group compared to the sham-control group at 12 months.

  Baseline to 12 Months

Study Arms (2)

VIA Disc NP

EXPERIMENTAL

A single dose, intradiscal delivery of 100mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered at up to two affected levels, L1-S1.

Other: VIA Disc NP

Sham

SHAM COMPARATOR

The procedure will be identical to the investigational procedure with the following exception: A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. No saline or VIA Disc NP will be injected.

Other: Sham

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 NP

Sham OTHER

A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. No saline or VIA Disc NP will be injected.

Sham

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 to 85 years old
• Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
• Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
• Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
• ODI score of ≥ 40 to ≤ 80
• Positive sustained hip flexion test
• Demonstrated intolerance to sitting
• Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• 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
• Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater
• Disc height of less than 4mm for any disc between L1-S1
• Symptomatic vertebral compression fracture
• Previous surgical treatment of the lumbar spine
• History of sacroiliac (SI) joint fusion within the past six months
• Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, provocative or anesthetic discography, SI joint pain injection, injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure
• Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)
• Received prior intradiscal stem cell/progenitor cell therapy or other biological intervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0 procedure
• Evidence of dynamic instability on lumbar flexion-extension radiographs (\>3 mm)
• Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes adjacent to the target disc
• Radiographic evidence of a full thickness annular tear at the target disc or other abnormal disc morphology
• Clinical suspicion of facet pain as primary pain generator
• A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, recent history of myocardial infarction, uncontrolled diabetes (\>7.0% HbA1C), etc.)
• Received VIA Disc NP previously.

Sponsors & Collaborators

• VIVEX Biologics, Inc.: lead

Study Sites (19)

Interventional Pain Management Napa Valley Orthopedic Medical Group

Napa, California, 94558, United States

RECRUITING

Source Healthcare

Santa Monica, California, 90403, United States

RECRUITING

Premier Spine and Pain Institute

Thornton, Colorado, 80229, United States

RECRUITING

The Orthopaedic Institute

Gainesville, Florida, 32607, United States

RECRUITING

Georgia Pain Management

Woodstock, Georgia, 30189, United States

RECRUITING

Henry Community Health

New Castle, Indiana, 47362, United States

RECRUITING

University of Kansas

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40504, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70115, United States

RECRUITING

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

RECRUITING

Paradigm Health System

Slidell, Louisiana, 70458, United States

RECRUITING

Nevada Advanced Pain Specialists

Reno, Nevada, 89511, United States

RECRUITING

Premier Pain Centers

Shrewsbury, New Jersey, 07702, United States

RECRUITING

Northwell Health

New York, New York, 10019, United States

RECRUITING

Crystal Coast Pain Management

New Bern, North Carolina, 28560, United States

RECRUITING

Pacific Sports & Spine

Eugene, Oregon, 97404, United States

RECRUITING

Procura Pain & Spine

Shenandoah, Texas, 77384, United States

RECRUITING

Precision Spine Care

Tyler, Texas, 75701, United States

RECRUITING

The Spine and Nerve Center C/O Clinical Research

Charleston, West Virginia, 25301, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Leslie Zaccari

CONTACT

714-366-6457; lzaccari@vivex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to 496 subjects at up to 20 investigational sites in the United States.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)