Evaluating a new treatment for painful disc degeneration
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
Run by VIVEX Biologics, Inc. · NCT06778447 · Data updated 2026-11-12
This study is testing a new non-surgical treatment for people with painful disc degeneration to see if it can help relieve their back pain when other treatments haven't worked.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years to 85 Years |
| Sex | All |
| Enrollment | 325 (estimated) |
| Sponsor | VIVEX Biologics, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 19 sites (Napa, California and 18 other locations) |
| Status | Recruiting |
| Started | February 17, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2028 |
| Registry record updated | September 14, 2026 |
| Trial ID | NCT06778447 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 22 to 85 with chronic low-back pain due to early to moderate degenerative disc disease unresponsive to conservative treatments.
✕Probably not a fit
Patients with severe degenerative disc disease or those who have not experienced chronic pain for at least six months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study assesses the safety and effectiveness of VIA Disc NP, a non-surgical intervention designed to supplement nucleus pulposus tissue in degenerated intervertebral discs. Participants suffering from lumbar discogenic pain due to degenerative disc disease will receive one treatment of VIA Disc NP at each affected level, with a maximum of two levels treated. The study is prospective, multi-center, single-arm, and open-label, focusing on individuals who have not found relief from conservative care for at least six months.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients suffering from degenerative disc disease.
How similar studies have gone: While this approach is innovative, similar studies evaluating non-surgical interventions for disc degeneration have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where it's running
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Interventional Pain Management Napa Valley Orthopedic Medical Group
Napa, California, United States Recruiting -
Source Healthcare
Santa Monica, California, United States Recruiting -
Premier Spine and Pain Institute
Thornton, Colorado, United States Recruiting -
The Orthopaedic Institute
Gainesville, Florida, United States Recruiting -
Georgia Pain Management
Woodstock, Georgia, United States Recruiting -
Henry Community Health
New Castle, Indiana, United States Recruiting
Show 13 more locations
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University of Kansas
Kansas City, Kansas, United States Recruiting -
University of Kentucky
Lexington, Kentucky, United States Recruiting -
Ochsner Clinic Foundation
New Orleans, Louisiana, United States Recruiting -
Spine Institute of Louisiana
Shreveport, Louisiana, United States Recruiting -
Paradigm Health System
Slidell, Louisiana, United States Recruiting -
Nevada Advanced Pain Specialists
Reno, Nevada, United States Recruiting -
Premier Pain Centers
Shrewsbury, New Jersey, United States Recruiting -
Northwell Health
New York, New York, United States Recruiting -
Crystal Coast Pain Management
New Bern, North Carolina, United States Recruiting -
Pacific Sports & Spine
Eugene, Oregon, United States Recruiting -
Procura Pain & Spine
Shenandoah, Texas, United States Recruiting -
Precision Spine Care
Tyler, Texas, United States Recruiting -
The Spine and Nerve Center C/O Clinical Research
Charleston, West Virginia, United States Recruiting
Study contacts
- Study coordinator: Jennifer Martin
- Email: jmartin@vivex.com
- Phone: 303-378-9778
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Two-Level Spinal Fusion for Disc Degeneration or Deformity: MDT-0123 compared with Autologous Bone Graft
This study tests MDT-0123 against the patient’s own bone graft to see which helps two-level spine fusion better in people with disc degeneration or spinal deformity.
-
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IDCT (Intradiscal Cell Therapy) for single-level mild-to-moderate lumbar degenerative disc disease
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Comparing two bioactive bone substitutes to help spinal fusion after anterior lumbar surgery
This trial tests two osteoinductive bioactive bone substitutes to see which better helps adults with degenerative lumbar disc disease achieve spinal fusion after anterior lumbar interbody surgery.
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Novosis Putty used with transforaminal lumbar interbody fusion for lumbar degenerative disc disease
The trial will test whether using Novosis Putty during transforaminal lumbar interbody fusion helps adults with lumbar degenerative disc disease heal better compared with standard care.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.