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Evaluating a new treatment for painful disc degeneration

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

Not applicable Interventional VIVEX Biologics, Inc. · NCT06778447

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

PhaseNot applicable
Study typeInterventional
Enrollment496 (estimated)
Ages22 Years to 85 Years
SexAll
SponsorVIVEX Biologics, Inc. Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone
Locations19 sites (Napa, California and 18 other locations)
Trial IDNCT06778447 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While this approach is innovative, similar studies evaluating non-surgical interventions for disc degeneration have shown promising results.

Eligibility criteria

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
* Demonstrated intolerance to 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
* Disc height of less than 4mm for any disc between L1-S1
* 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, provocative or anesthetic discography, 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)
* 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; subjects 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, leg pain, cauda equine syndrome, etc.

Where this trial is running

Napa, California and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Degenerative Disc DiseaseDisc DegenerationLumbar Discogenic Pain
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.