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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.

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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.

Primary Outcome

The primary efficacy endpoint is the proportion of participants who achieve a minimal clinically important difference (MCID), defined as at least a 30% reduction in back pain VAS score from baseline to 12 months, in the VIA Disc NP group compared to that in the sham-control group.

Conditions Studied

Degenerative Disc Disease Disc Degeneration Lumbar Discogenic Pain

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

FieldValue
Enrollment Target 496 participants
Start Date 2025-02-17
Est. Completion 2028-05
Phase NA
VIVEX Biologics

6 total trials

What NCT06778447 shows while recruiting

NCT06778447 is an interventional study that assigns participants to a tested intervention. The registered 496 participants enrollment target is mid-sized for trials with a published cap, above the 157-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (216% higher).

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 names 20 study sites across 15 states, led by 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.

Learn More About Clinical Trials

Similar trials for Degenerative Disc Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06778447's enrollment target sits among peer trials

496 3rd of 42 higher than 40 of 42 other Degenerative Disc Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Degenerative Disc Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06778447

Source: ClinicalTrials.gov NCT06778447, the US trial registry maintained by the National Library of Medicine. NCT06778447 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.