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RECRUITING
NCT06778447
NA

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

Sponsor: VIVEX Biologics, Inc.

View on ClinicalTrials.gov

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.

Official title: Randomized, Sham-Controlled, Multi-Center, Double-Blind Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft to Supplement Nucleus Pulposus Tissue in Participants With Lumbar Discogenic Pain Associated With Degenerative Disc Disease

Key Details

Gender

All

Age Range

22 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

496

Start Date

2025-02-17

Completion Date

2028-05

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

OTHER

VIA Disc NP

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

OTHER

Sham

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.

Locations (20)

Interventional Pain Management Napa Valley Orthopedic Medical Group

Napa, California, United States

Source Healthcare

Santa Monica, California, United States

Premier Spine and Pain Institute

Thornton, Colorado, United States

The Orthopaedic Institute

Gainesville, Florida, United States

Georgia Pain Management

Woodstock, Georgia, United States

Henry Community Health

New Castle, Indiana, United States

University of Kansas

Kansas City, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Paradigm Health System

Slidell, Louisiana, United States

Nevada Advanced Pain Specialists

Reno, Nevada, United States

Premier Pain Centers

Shrewsbury, New Jersey, United States

Northwell Health

New York, New York, United States

Crystal Coast Pain Management

New Bern, North Carolina, United States

Pacific Sports & Spine

Eugene, Oregon, United States

Pain Specialists of America

Killeen, Texas, United States

Procura Pain & Spine

Shenandoah, Texas, United States

Precision Spine Care

Tyler, Texas, United States

The Spine and Nerve Center C/O Clinical Research

Charleston, West Virginia, United States