Actively Recruiting
Randomized, Sham-Controlled, Double-Blind Clinical Trial Evaluating VIA Disc NP for Lumbar Discogenic Pain in Degenerative Disc Disease
Led by VIVEX Biologics, Inc. · Updated on 2026-04-24
496
Participants Needed
19
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the safety and effectiveness of VIA Disc NP, a non-surgical treatment designed to supplement nucleus pulposus tissue in people experiencing lumbar discogenic pain due to degenerative disc disease (DDD). The study is a randomized, sham-controlled, double-blind trial conducted across multiple centers, including an initial open-label roll-in phase for one participant per site. It focuses on adults aged 22 to 85 years with moderate to severe disc degeneration confirmed by MRI and persistent low-back pain unresponsive to conservative care. Participants receive a single intradiscal injection of VIA Disc NP, which is made from processed cadaveric disc tissue, at up to two affected lumbar levels (L1-S1). Participants who enroll after the roll-in phase are randomly assigned in a 2:1 ratio to receive either the VIA Disc NP injection or a sham procedure where a needle is inserted but no injection is given. Those initially assigned to the sham group who continue to have symptoms after 12 months may cross over to receive VIA Disc NP and undergo an additional 12 months of follow-up. During the study, participants will be monitored through assessments including pain severity using the Visual Analog Scale (VAS) and safety evaluations for any treatment-related adverse events over a 12-month period. The primary outcomes measure the proportion of participants achieving meaningful improvement in pain scores and the incidence of treatment-related side effects. The study duration includes screening, treatment, and follow-up visits, with careful tracking of participants' symptoms and safety throughout the trial.
CONDITIONS
Brief Title
Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 to 85 years old
- Diagnosis of moderate to severe degenerative disc disease confirmed by MRI, Modified Pfirrmann Grade 3-7
- Chronic axial midline low-back pain for at least 6 months unresponsive to at least 3 months of conservative care
- Low-back pain severity score between 40 and 90 mm on the Visual Analog Scale
- Oswestry Disability Index (ODI) score between 40 and 80
- Positive sustained hip flexion test
- Demonstrated intolerance to sitting
- Able and willing to provide written informed consent
- Willing and able to comply with all study procedures and available for study duration with life expectancy over 2 years
You will not qualify if you...
- Contraindications to sedation or anesthetic protocols
- More than two lumbar discs affected by degeneration (3 or more discs with Modified Pfirrmann grade 3 or higher)
- Disc height less than 4 mm between L1 and S1
- Symptomatic vertebral compression fracture
- Prior lumbar spine surgery
- Sacroiliac joint fusion within past 6 months
- Received certain lumbar injections or procedures within 3 months prior to Day 0 procedure
- Previous intradiscal stem cell or biological therapy at target level within 12 months
- Evidence of lumbar instability or significant spinal conditions (e.g., grade 2+ spondylolisthesis, spondylitis)
- Full thickness annular tear or abnormal disc morphology
- Clinical suspicion of facet joint pain as primary source
- Unstable systemic diseases or infections
- Prior VIA Disc NP treatment
- Substance abuse or opioid use over 90 MME/day
- Current radiation, chemotherapy, immunosuppression, or chronic steroid therapy above allowed dose
- Metal or ceramic implants in lumbar spine
- Contraindications to MRI including incompatible devices
- Recent litigation related to back pain
- Unmanaged psychiatric conditions or recent medication changes
- Traumatic neurological disorders impacting study
- Pregnant or breastfeeding women or those not using reliable contraception
- Use of experimental treatments for same condition within 6 months
- Other persistent nerve or pain conditions like radiculopathy or cauda equina syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive a single dose of VIA Disc NP or a sham procedure for lumbar discogenic pain.
Multiple visits during the 12 months for assessments
Trial Site Locations
Total: 19 locations
1
Interventional Pain Management Napa Valley Orthopedic Medical Group
Napa, California, United States, 94558
Actively Recruiting
2
Source Healthcare
Santa Monica, California, United States, 90403
Actively Recruiting
3
Premier Spine and Pain Institute
Thornton, Colorado, United States, 80229
Actively Recruiting
4
The Orthopaedic Institute
Gainesville, Florida, United States, 32607
Actively Recruiting
5
Georgia Pain Management
Woodstock, Georgia, United States, 30189
Actively Recruiting
6
Henry Community Health
New Castle, Indiana, United States, 47362
Actively Recruiting
7
University of Kansas
Kansas City, Kansas, United States, 66160
Actively Recruiting
8
University of Kentucky
Lexington, Kentucky, United States, 40504
Actively Recruiting
9
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70115
Actively Recruiting
10
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
Actively Recruiting
11
Paradigm Health System
Slidell, Louisiana, United States, 70458
Actively Recruiting
12
Nevada Advanced Pain Specialists
Reno, Nevada, United States, 89511
Actively Recruiting
13
Premier Pain Centers
Shrewsbury, New Jersey, United States, 07702
Actively Recruiting
14
Northwell Health
New York, New York, United States, 10019
Actively Recruiting
15
Crystal Coast Pain Management
New Bern, North Carolina, United States, 28560
Actively Recruiting
16
Pacific Sports & Spine
Eugene, Oregon, United States, 97404
Actively Recruiting
17
Procura Pain & Spine
Shenandoah, Texas, United States, 77384
Actively Recruiting
18
Precision Spine Care
Tyler, Texas, United States, 75701
Actively Recruiting
19
The Spine and Nerve Center C/O Clinical Research
Charleston, West Virginia, United States, 25301
Actively Recruiting
Research Team
L
Leslie Zaccari
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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