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Clinical Trial for Degenerative Disc Disease with VIA Disc NP

This study is testing a new treatment called VIA Disc NP for people with degenerative disc disease (DDD), which causes chronic low back pain. VIA Disc NP is made from donated disc tissue and is designed to help repair damaged discs. You might be eligible if you are between 22 and 85 years old, have moderate to severe DDD, and your back pain hasn't improved with at least three months of other treatments. The study will look at how much your pain improves after 12 months (measured by a VAS score) and if there are any side effects. The study is currently recruiting about 496 participants, but its overall status is unclear.

Study design
This is a randomized, sham-controlled, multi-center, double-blind study. Participants will either receive the VIA Disc NP injection or a sham procedure, where a needle is inserted but no medicine is injected.
What's involved
Participants will receive one VIA Disc NP treatment or sham procedure to up to two affected disc levels. The study will measure your pain and safety at 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and effectiveness for 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06778447

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

Recruiting
NAAges 22–85InterventionalTreatment
VIVEX Biologics, Inc.
~325 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:VIA Disc NPSham

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months.
Measured over Baseline to 12 Months
+1 more outcome measured

Conditions

Degenerative Disc Disease
Disc Degeneration
Lumbar Discogenic Pain

Explore related trials

Intervertebral Disc Degenerative DisorderLumbar discogenic pain

NCT06778447

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Spine and Nerve Center C/O Clinical Research

    Charleston, West Virginiastudy coordinator listed

    Recruiting

  • Crystal Coast Pain Management

    New Bern, North Carolinano site contact published

    Recruiting

  • Georgia Pain Management

    Woodstock, Georgiano site contact published

    Recruiting

  • Henry Community Health

    New Castle, Indianano site contact published

    Recruiting

  • Interventional Pain Management Napa Valley Orthopedic Medical Group

    Napa, Californiano site contact published

    Recruiting

  • Nevada Advanced Pain Specialists

    Reno, Nevadano site contact published

    Recruiting

  • Northwell Health

    New York, New Yorkno site contact published

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisianano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jennifer Martin
[email protected]
303-378-9778
Email the study team

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Eligibility criteria

Inclusion

Age 22 to 85 years old
Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
ODI score of ≥ 40 to ≤ 80
Positive sustained hip flexion test
Intolerance to prolonged sitting
Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years

Exclusion

Contraindications to the proposed sedation/anesthetic protocol
Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater
Symptomatic vertebral compression fracture
Previous surgical treatment of the lumbar spine
History of sacroiliac (SI) joint fusion within the past six months
Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, SI joint pain injection, injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure
Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)
Received prior intradiscal stem cell/progenitor cell therapy or other biological intervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0 procedure
Evidence of dynamic instability on lumbar flexion-extension radiographs (\>3 mm) at any level
Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes adjacent to the target disc
Radiographic evidence of a full thickness annular tear at the target disc or other abnormal disc morphology
Clinical suspicion of facet pain as primary pain generator
A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, recent history of myocardial infarction, uncontrolled diabetes (\>7.0% HbA1C), etc.)
Received VIA Disc NP previously.
Deemed unsuitable for clinical study participation by the Investigator
Evidence of substance abuse (including marijuana); note: subjects using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within the 3 months prior to screening and subjects on long-acting opioids may be given option to wean off opiates before enrollment; participants on short-acting opiates (e.g., hydrocodone, oxycodone, tramadol, etc.) may be included and utilization monitored after the treatment
Opioid use of more than 90 MME/day
Currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd, or inhalation steroids for asthma is allowed)
Metal or ceramic implants in the lumbar spine region
Contraindications to MRI, including non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.
Involved in ongoing or closed (within 6 months of screening visit) litigation related to their back pain condition
Any mental instability, unstable bipolar disorders, unmanaged post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression and/or require new or changed anti-depressants or anti-psychotic medications within 3 months of enrollment
Diagnosis of any traumatic neurological disorders that may impact the study as per the judgement of the Investigator
Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study; pregnancy is confirmed by:
a positive pregnancy test during the screening visit
self-reported pregnancy
Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)
Received any experimental drug or device to treat the same condition used within 6 months prior to the screening visit or during the course of the clinical trial
Other persistent pain/nerve issues including, for example, radiculopathy, cauda equine syndrome, etc.

What this trial measures

  • Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months.Baseline to 12 Months

    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.

  • Primary Safety Endpoint - Proportion of participants reporting treatment-related AEs at 12 months.Baseline to 12 Months

    The primary safety endpoint will be the proportion of participants that experience one or more treatment-related (Investigational Product (IP) or procedure), adverse events (AE) in the VIA Disc NP group compared to the sham-control group at 12 months.