Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease

NCT06778447 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

VIVEX Biologics

4 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVEX Biologics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06778447 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Louisiana, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06778447?

The interventions under investigation include: Sham (OTHER), VIA Disc NP (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06778447?

This trial is sponsored by VIVEX Biologics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial