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New injection could ease back pain without surgery

NCT ID NCT06778447

Disease control Sponsor: VIVEX Biologics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tests a one-time injection called VIA Disc NP for people with long-term low-back pain caused by disc disease. The injection adds material to the damaged disc to help cushion it. About 496 adults will receive either the real injection or a sham procedure, and researchers will check if it reduces pain by at least 30% after 12 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 325 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disc disease Disc degeneration Lumbar discogenic pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Crystal Coast Pain Management

    RECRUITING

    New Bern, North Carolina, 28560, United States

  • Georgia Pain Management

    RECRUITING

    Woodstock, Georgia, 30189, United States

  • Henry Community Health

    RECRUITING

    New Castle, Indiana, 47362, United States

  • Interventional Pain Management Napa Valley Orthopedic Medical Group

    RECRUITING

    Napa, California, 94558, United States

  • Nevada Advanced Pain Specialists

    RECRUITING

    Reno, Nevada, 89511, United States

  • Northwell Health

    RECRUITING

    New York, New York, 10019, United States

  • Ochsner Clinic Foundation

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • Pacific Sports & Spine

    RECRUITING

    Eugene, Oregon, 97404, United States

  • Paradigm Health System

    RECRUITING

    Slidell, Louisiana, 70458, United States

  • Precision Spine Care

    RECRUITING

    Tyler, Texas, 75701, United States

  • Premier Pain Centers

    RECRUITING

    Shrewsbury, New Jersey, 07702, United States

  • Premier Spine and Pain Institute

    RECRUITING

    Thornton, Colorado, 80229, United States

  • Procura Pain & Spine

    RECRUITING

    Shenandoah, Texas, 77384, United States

  • Source Healthcare

    RECRUITING

    Santa Monica, California, 90403, United States

  • Spine Institute of Louisiana

    RECRUITING

    Shreveport, Louisiana, 71101, United States

  • The Orthopaedic Institute

    RECRUITING

    Gainesville, Florida, 32607, United States

  • The Spine and Nerve Center C/O Clinical Research

    RECRUITING

    Charleston, West Virginia, 25301, United States

  • University of Kansas

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40504, United States

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