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Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
Sponsor: VIVEX Biologics, Inc.
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
VIA Disc NP
VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.
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