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NCT06778447 · ClinicalTrials.gov registry record · NA
Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
A NA study of Degenerative Disc Disease and Disc Degeneration, sponsored by VIVEX Biologics.
- Recruiting
- Registry status
- NA
- Development phase
- 496
- Enrollment target
- 20
- Study locations
NCT06778447: Recruiting NA study of Degenerative Disc Disease and Disc Degeneration, sponsored by VIVEX Biologics.
NCT06778447 is a NA study of Degenerative Disc Disease and Disc Degeneration that is actively recruiting participants, run by VIVEX Biologics. The registered enrollment target is 496 participants, above the 157-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (216% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06778447, a NA study of Degenerative Disc Disease and Disc Degeneration, is actively recruiting participants, sponsored by VIVEX Biologics.
- RECRUITING
- Registry status
- NA
- Development phase
- 496 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- OTHER Sham
- OTHER VIA Disc NP
Study Locations (20)
Louisiana
- Ochsner Clinic Foundation - New Orleans
- Spine Institute of Louisiana - Shreveport
- Paradigm Health System - Slidell
Texas
- Pain Specialists of America - Killeen
- Procura Pain & Spine - Shenandoah
- Precision Spine Care - Tyler
California
- Interventional Pain Management Napa Valley Orthopedic Medical Group - Napa
- Source Healthcare - Santa Monica
Colorado
- Premier Spine and Pain Institute - Thornton
Florida
- The Orthopaedic Institute - Gainesville
Georgia
- Georgia Pain Management - Woodstock
Indiana
- Henry Community Health - New Castle
Kansas
- University of Kansas - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2025-02-17 |
| Est. Completion | 2028-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06778447
The ClinicalTrials.gov registry entry for NCT06778447 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 157-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (216% higher). The listed sponsor is VIVEX Biologics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.
NCT06778447 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Louisiana, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06778447 about?
NCT06778447 is a clinical study titled "Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease". 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 lu...
What is the current status of trial NCT06778447?
This trial is currently recruiting. It is a NA study. The enrollment target is 496 participants. The study started on 2025-02-17. Estimated completion is 2028-05.
What conditions does trial NCT06778447 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Disc Degeneration, Lumbar Discogenic Pain.
What interventions are being tested in trial NCT06778447?
The interventions under investigation include: Sham (OTHER), VIA Disc NP (OTHER).
Who is sponsoring clinical trial NCT06778447?
This trial is sponsored by VIVEX Biologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06778447 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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