Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
Sponsor: VIVEX Biologics, Inc. • ClinicalTrials.gov ID: NCT06778447
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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.
Interventions
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VIA Disc NP
(Other)
VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.
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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.
Eligibility criteria
Conditions
Locations
- 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
- 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
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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