Actively Recruiting
Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
Led by VIVEX Biologics, Inc. · Updated on 2026-04-24
496
Participants Needed
19
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 on MRI, Modified Pfirrmann Grade 3-7
- Chronic axial midline low-back pain without lower extremity motor, sensory, or reflex changes for at least 6 months
- Low-back pain not relieved by at least 3 months of conservative care
- Low-back pain severity between 40 and 90 mm on the Visual Analog Scale
- Oswestry Disability Index score between 40 and 80
- Positive sustained hip flexion test
- Demonstrated intolerance to sitting
- Able to provide voluntary, written informed consent
- Willing and able to comply with study procedures and have life expectancy over 2 years
You will not qualify if you...
- Contraindications to sedation or anesthetic protocol
- More than two lumbar discs involved (3 or more discs with Modified Pfirrmann grade 3 or higher)
- Disc height less than 4mm between L1 and S1
- Symptomatic vertebral compression fracture
- Previous lumbar spine surgery
- Sacroiliac joint fusion within past 6 months
- Recent lumbar injections or procedures within 3 months prior to Day 0
- Prior intradiscal stem cell or biological therapy at target level within 12 months
- Lumbar instability greater than 3 mm on flexion-extension X-rays
- Grade 2 or higher spondylolisthesis, lumbar spondylitis, or Type III Modic changes
- Full thickness annular tear or abnormal disc morphology
- Facet joint pain as primary pain source
- Unstable systemic disease or infection
- Previous VIA Disc NP treatment
- Substance abuse or opioid use over 90 MME/day
- Current radiation, chemotherapy, immunosuppression, or chronic steroid use exceeding allowed doses
- Metal or ceramic lumbar implants
- MRI contraindications including incompatible implants
- Ongoing or recent litigation related to back pain
- Mental health instability or recent medication changes
- Traumatic neurological disorders affecting study participation
- Pregnancy or breastfeeding, or unreliable contraception in women of childbearing potential
- Recent use of experimental treatments for the same condition
- Other persistent nerve or pain conditions such as radiculopathy or cauda equina syndrome
AI-Screening
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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
CONTACT
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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