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Recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT06778447

Public ClinicalTrials.gov record NCT06778447. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 12:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06778447
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
VIVEX Biologics, Inc.
Industry
Enrollment
325 participants

Conditions and interventions

Eligibility (public fields only)

Age range
22 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 17, 2025 (Actual)
Primary completion
Oct 2027 (Estimated)
Completion
Oct 2028 (Estimated)
Last update posted
Sep 14, 2026

2025 – 2028

United States locations

U.S. sites
19
U.S. states
15
U.S. cities
19
Facility City State ZIP Site status
Interventional Pain Management Napa Valley Orthopedic Medical Group Napa California 94558 Recruiting
Source Healthcare Santa Monica California 90403 Recruiting
Premier Spine and Pain Institute Thornton Colorado 80229 Recruiting
The Orthopaedic Institute Gainesville Florida 32607 Recruiting
Georgia Pain Management Woodstock Georgia 30189 Recruiting
Henry Community Health New Castle Indiana 47362 Recruiting
University of Kansas Kansas City Kansas 66160 Recruiting
University of Kentucky Lexington Kentucky 40504 Recruiting
Ochsner Clinic Foundation New Orleans Louisiana 70115 Recruiting
Spine Institute of Louisiana Shreveport Louisiana 71101 Recruiting
Paradigm Health System Slidell Louisiana 70458 Recruiting
Nevada Advanced Pain Specialists Reno Nevada 89511 Recruiting
Premier Pain Centers Shrewsbury New Jersey 07702 Recruiting
Northwell Health New York New York 10019 Recruiting
Crystal Coast Pain Management New Bern North Carolina 28560 Recruiting
Pacific Sports & Spine Eugene Oregon 97404 Recruiting
Procura Pain & Spine Shenandoah Texas 77384 Recruiting
Precision Spine Care Tyler Texas 75701 Recruiting
The Spine and Nerve Center C/O Clinical Research Charleston West Virginia 25301 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06778447, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 14, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06778447 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →