Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease (NCT06778447)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Interventional Pain Management Napa Valley Orthopedic Medical Group — Napa, California
Age range: 22 Years to 85 Years
🧪 Interventions in This Study
- VIA Disc NP (OTHER)
- Sham (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- Interventional Pain Management Napa Valley Orthopedic Medical Group — Napa, California
- Source Healthcare — Santa Monica, California
- Premier Spine and Pain Institute — Thornton, Colorado
- The Orthopaedic Institute — Gainesville, Florida
- Georgia Pain Management — Woodstock, Georgia
- Henry Community Health — New Castle, Indiana
- University of Kansas — Kansas City, Kansas
- University of Kentucky — Lexington, Kentucky
- Ochsner Clinic Foundation — New Orleans, Louisiana
- Spine Institute of Louisiana — Shreveport, Louisiana
- Paradigm Health System — Slidell, Louisiana
- Nevada Advanced Pain Specialists — Reno, Nevada
- Premier Pain Centers — Shrewsbury, New Jersey
- Northwell Health — New York, New York
- Crystal Coast Pain Management — New Bern, North Carolina
- Pacific Sports & Spine — Eugene, Oregon
- Procura Pain & Spine — Shenandoah, Texas
- Precision Spine Care — Tyler, Texas
- The Spine and Nerve Center C/O Clinical Research — Charleston, West Virginia
📞 Contact the Study Coordinator
Phone: (714) 366-6457
Email: lzaccari@vivex.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain — Phoenix, Arizona
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Explore by condition: All Degenerative Disc Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.