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Protein-Powered bone graft put to the test in spinal fusion surgery

NCT ID NCT03810573

Disease control Sponsor: Bone Biologics Corp 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 15, 2026 · Last updated Oct 16, 2026 · Updated 1 time

Summary

Researchers are testing a new bone graft material called NB1 in people with degenerative disc disease who are having a specific type of spinal fusion surgery called transforaminal lumbar interbody fusion. The study enrolls about 30 adults with up to mild spinal slippage (Grade I spondylolisthesis) at one spinal level between L2 and S1. Participants receive either NB1 or standard graft during surgery, and researchers track how well the bones fuse and whether any graft problems require reoperation. The trial also monitors safety, immune response, pain, and quality of life over 12 months.

What this could mean

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

Active substance
NB1 bone graft, a putty made from a bone protein called rhNELL-1 and a carrier material
What this could lead to
If it works, NB1 could offer surgeons another option to help spinal bones fuse during lumbar fusion surgery.
What could go wrong
This is a small, early-stage pilot study with about 30 participants, so results may not hold in larger trials. Spinal fusion surgery carries risks such as infection, bleeding, nerve injury, and the graft may fail to fuse, requiring further surgery.

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 30 people

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

Started

Mar 2024

Expected to finish

Dec 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

17 to 70 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: * Documented diagnosis of degenerative disc disease * Up to Grade I spondylolisthesis * Eligible to undergo a single vertebral level spine fusion (L2 to S1) Exclusion Criteria: * Previous spinal instrumentation or previous interbody fusion procedure at the involved level * Grade II or greater spondylolisthesis * Systemic or local infection at the site of surgery

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder spondylolisthesis

As listed by the trial registrant

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

Degenerative disc disease Spondylolisthesis

How to take part

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

  1. The places running it

    2 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

  • Monash Medical Center

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • St Vincent Melbourne

    RECRUITING

    Fitzroy, Australia

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