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Degenerative Disc DiseaseRESTORENCT06778447

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

A study testing VIA Disc NP in people with Degenerative Disc Disease and Disc Degeneration, run by VIVEX Biologics, Inc. at 19 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 22 to 85 years
What is being tested?
VIA Disc NP
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
325 participants
Where
19 sitesUnited States
Study dates
17 Feb 2025to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Martin contact

303-378-9778

jmartin@vivex.com

19 sites in 1 country

United States19 sites, 19 recruiting

  • The Spine and Nerve Center C/O Clinical Research

    Charleston, West Virginia, 25301

    Amy Young, RN, 304-347-6144, amelia.young3@wvumedicine.org

    Tim Deer, National PI, MD

    Recruiting

  • Pacific Sports & Spine

    Eugene, Oregon, 97404

    Katie Fabian

    Greg Moore, MD

    Recruiting

  • The Orthopaedic Institute

    Gainesville, Florida, 32607

    Aldrin Yumil

    Ajay Antony, MD

    Recruiting

  • University of Kansas

    Kansas City, Kansas, 66160

    Karina Bravo

    Usman Latif, MD

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40504

    Katie Eastridge

    Christopher Mallard, MD

    Recruiting

  • Interventional Pain Management Napa Valley Orthopedic Medical Group

    Napa, California, 94558

    Sarah Habib

    Jackie Weisbein, MD

    Recruiting

  • Crystal Coast Pain Management

    New Bern, North Carolina, 28560

    Amy Harum

    Kirk Harum, MD

    Recruiting

  • Henry Community Health

    New Castle, Indiana, 47362

    Rebecca Layman

    Andrew Davisson, MD

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70115

    Raquel Walker

    Maged Guirguis, MD

    Recruiting

  • Northwell Health

    New York, New York, 10019

    Jarka Faruq

    Kiran Patel, MD

    Recruiting

  • Nevada Advanced Pain Specialists

    Reno, Nevada, 89511

    Madeline Benson

    Denis Patterson, DO

    Recruiting

  • Source Healthcare

    Santa Monica, California, 90403

    Gabriel Wirnowski

    Tim Davis, MD

    Recruiting

  • Procura Pain & Spine

    Shenandoah, Texas, 77384

    Courtney Harvey

    Thomas White, MD

    Recruiting

  • Spine Institute of Louisiana

    Shreveport, Louisiana, 71101

    Krista Kachnik

    Pierce Nunley, MD

    Recruiting

  • Premier Pain Centers

    Shrewsbury, New Jersey, 07702

    Kathryn Gee

    Sean Li, MD

    Recruiting

  • Paradigm Health System

    Slidell, Louisiana, 70458

    Chris Minnerly

    Thomas Myers, MD

    Recruiting

  • Premier Spine and Pain Institute

    Thornton, Colorado, 80229

    Dennis Dickman

    Amar Patel, MD

    Recruiting

  • Precision Spine Care

    Tyler, Texas, 75701

    Jessica Youngblood

    Aaron Calodney, MD

    Recruiting

  • Georgia Pain Management

    Woodstock, Georgia, 30189

    Tina Hall

    James Ellner, MD

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
VIA Disc NP, Sham
Keywords
Degenerative Disc Disease, Lumbar Discogenic Pain
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIA Disc NPOther

    Also called VIA Disc Nucleus Pulposus Allograft

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

  • ShamOther

    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.

Study groups in NCT06778447
Study groupRoleWhat they receive
VIA Disc NPExperimentalA 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.
Receives: Other: VIA Disc NP
ShamSham comparatorThe 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.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from 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.

    Measured: Baseline to 12 Months

  2. Primary Safety Endpoint - Proportion of participants reporting treatment-related AEs at 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.

    Measured: Baseline to 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start17 Feb 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Up to 325 subjects at up to 21 investigational sites in the United States.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
325 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06778447
Sponsor's protocol ID
VIA-2024-002
Acronym
RESTORE
Status last verified
Sep 2026
First submitted
10 Jan 2025
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deer TR, Nunley PD, Naidu RK, Beall DP, Davis TT, Calodney AK, Soin A, Lorio MP, Block JE. Safety and efficacy of intradiscal nucleus pulposus allograft versus sham for lumbar discogenic pain associated with degenerative disc disease: study protocol for a randomized clinical trial. Trials. 2026 Jun 8. doi: 10.1186/s13063-026-09826-w. Online ahead of print.

    PubMed 42260665

Questions about this trial

What is this clinical trial studying?

A study testing VIA Disc NP in people with Degenerative Disc Disease and Disc Degeneration, run by VIVEX Biologics, Inc. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Martin (303-378-9778, jmartin@vivex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06778447, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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