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Could a disc injection replace surgery for back pain?

NCT ID NCT06615505

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a single injection of VIA Disc NP, a processed human disc tissue, for people with long-term lower back pain from degenerated discs. About 121 participants will receive either the injection or a sham procedure. The goal is to see if the injection safely reduces pain and improves function over 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VIA Disc NP (a processed human disc tissue allograft injected into the disc)
What this could lead to
If it works, this could offer a new, non-surgical option to reduce back pain and improve function for people with degenerated discs.
What could go wrong
This is an early phase 2 trial with only 121 participants, so results may not apply to everyone. The sham procedure may also produce some benefit, making it hard to prove the treatment works.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

121 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Nov 2027

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.

Key Inclusion Criteria: 1. Age 22 to 85 years old 2. Diagnosis of early to moderate DDD, Modified Pfirrmann Grade 3-7 3. Chronic axial midline low-back pain 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 4. Positive hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening 5. Demonstrated intolerance to sitting for more than 30 minutes at a time based on self-report or assessed by a qualified healthcare professional at the screening visit 6. Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS at the time of Screening 7. ODI score of ≥ 40 to ≤ 80 at the time of Screening Key Exclusion Criteria: 1. Contraindication to MRI for any reason 2. Contraindications to the proposed sedation/anesthetic protocol 3. Symptomatic involvement of more than two lumbar discs 4. Fracture of the lumbar spine, previous lumbar spine surgery or previous treatment of the target disc(s) 5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc 6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology 7. Clinical suspicion of facet pain as primary pain generator 8. 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 9. Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)

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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

Contacts and locations

Locations

  • Australian Medical Research

    Hurstville, New South Wales, 2220, Australia

  • Cercare Clinical Research

    Wayville, South Australia, 5034, Australia

  • Genesis Research Services Pty Ltd

    Broadmeadow, New South Wales, 2292, Australia

  • Monash House Research Centre Pty Ltd

    Clayton, Victoria, 3168, Australia

  • Sydney Pain Research Centre

    Wahroonga, New South Wales, 2076, Australia

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