Recruiting

VIA Disc NP

Sponsor:

VIVEX Biologics, Inc.

Code:

NCT06778447

Conditions

Degenerative Disc Disease

Disc Degeneration

Lumbar Discogenic Pain

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

VIA Disc NP

Sham

Study Details

Brief summary:

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

Degenerative Disc Disease

Disc Degeneration

Lumbar Discogenic Pain

Study ID

NCT06778447

Start date

Feb 17, 2025

Status verified date

Apr, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

496 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VIA Disc NP

A single dose, intradiscal delivery of 100mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered at up to two affected levels, L1-S1.

sham comparator: Sham

The procedure will be identical to the investigational procedure with the following exception: A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. No saline or VIA Disc NP will be injected.

Interventions

VIA Disc NP

VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.

Sham

A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. No saline or VIA Disc NP will be injected.

Primary outcome measure

  • Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months. [ Time Frame: Baseline to 12 Months ]
  • Primary Safety Endpoint - Proportion of participants reporting treatment-related AEs at 12 months. [ Time Frame: Baseline to 12 Months ]

Central Contacts and Locations

Central contacts

Leslie Zaccari

714-366-6457lzaccari@vivex.com

Locations

Interventional Pain Management Napa Valley Orthopedic Medical Group

Recruiting

Napa, California, United States, 94558

Principal Investigator:

Jackie Weisbein, MD

Source Healthcare

Recruiting

Santa Monica, California, United States, 90403

Principal Investigator:

Tim Davis, MD

Premier Spine and Pain Institute

Recruiting

Thornton, Colorado, United States, 80229

Principal Investigator:

Amar Patel, MD

The Orthopaedic Institute

Recruiting

Gainesville, Florida, United States, 32607

Principal Investigator:

Ajay Antony, MD

Georgia Pain Management

Recruiting

Woodstock, Georgia, United States, 30189

Principal Investigator:

James Ellner, MD

Henry Community Health

Recruiting

New Castle, Indiana, United States, 47362

Principal Investigator:

Andrew Davisson, MD

University of Kansas

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

Usman Latif, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40504

Principal Investigator:

Christopher Mallard, MD

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70115

Principal Investigator:

Maged Guirguis, MD

Spine Institute of Louisiana

Recruiting

Shreveport, Louisiana, United States, 71101

Principal Investigator:

Pierce Nunley, MD

Paradigm Health System

Recruiting

Slidell, Louisiana, United States, 70458

Principal Investigator:

Thomas Myers, MD

Nevada Advanced Pain Specialists

Recruiting

Reno, Nevada, United States, 89511

Principal Investigator:

Denis Patterson, DO

Premier Pain Centers

Recruiting

Shrewsbury, New Jersey, United States, 07702

Principal Investigator:

Sean Li, MD

Northwell Health

Recruiting

New York, New York, United States, 10019

Principal Investigator:

Kiran Patel, MD

Crystal Coast Pain Management

Recruiting

New Bern, North Carolina, United States, 28560

Principal Investigator:

Kirk Harum, MD

Pacific Sports & Spine

Recruiting

Eugene, Oregon, United States, 97404

Principal Investigator:

Greg Moore, MD

Procura Pain & Spine

Recruiting

Shenandoah, Texas, United States, 77384

Principal Investigator:

Thomas White, MD

Precision Spine Care

Recruiting

Tyler, Texas, United States, 75701

Principal Investigator:

Aaron Calodney, MD

The Spine and Nerve Center C/O Clinical Research

Recruiting

Charleston, West Virginia, United States, 25301

Contacts

Amy Young, RN

304-347-6144amelia.young3@wvumedicine.org

Principal Investigator:

Tim Deer, National PI, MD

More Information

Sponsor

VIVEX Biologics, Inc.

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Degenerative Disc Disease
  • Lumbar Discogenic Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VIVEX Biologics, Inc. on 2026-04-24.