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Can a growth factor from donor bone improve spinal fusion?

NCT ID NCT07775729

Disease control Sponsor: Isto Biologics Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing whether ProteiOS®, a growth factor derived from donor bone, can help bones in the lower spine fuse together as effectively as the standard approach using a patient's own bone. Adults with degenerative spine conditions needing lumbar fusion surgery will be randomly assigned to receive either ProteiOS® or standard bone graft. The main goal is to see if ProteiOS® achieves a similar rate of successful fusion at 12 months, while also measuring pain, disability, and safety.

What this could mean

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

Active substance
ProteiOS® (allograft-derived growth factor) used as a bone graft substitute during spinal fusion surgery
What this could lead to
If successful, ProteiOS® could offer a safe and effective alternative to using a patient's own bone for spinal fusion, potentially reducing pain and improving recovery.
What could go wrong
This is a non-inferiority trial, meaning it aims to show ProteiOS® is not worse than standard care, not that it is better. The study is early and results may not confirm non-inferiority or long-term benefits.

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 280 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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

18 to 75 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 18-75 years, skeletally mature at time of surgery * Degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented TLIF, with or without posterolateral fusion, as determined by the treating surgeon * For the ALIF study site only: degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented ALIF * Radiographic evidence of degenerative lumbar disease on CT, MRI, or plain radiograph (decreased disc height, herniated nucleus pulposus, ligamentum flavum/annulus hypertrophy, facet arthrosis/osteophyte, spinal canal or foraminal stenosis, or vertebral translation \>3 mm) * Symptoms of low back pain, radiculopathy, or neurogenic claudication consistent with radiographic findings * Preoperative back pain ≥4 on a 0-10 VAS * Preoperative leg pain ≥3 on a 0-10 VAS, consistent with radiculopathy or neurogenic claudication * Preoperative ODI score ≥30 * Failure of ≥6 months non-operative treatment (may be waived for progressive neurological deficit, new/worsening motor weakness, bowel/bladder dysfunction, or cauda equina syndrome) * Willing and able to comply with follow-up schedule and provide written informed consent Exclusion Criteria: * Scheduled for surgery with synthetic bone grafts containing hydroxyapatite, tricalcium phosphate, or other radio-opaque material * BMI \>40 * Prior lumbar spine fusion surgery at a level currently scheduled for surgery * Malignancy or treatment for malignancy within the last 5 years (benign skin cancer permitted) * Osteoporosis/osteopenia (≤2.5 SD below age-matched mean) * Use of rhBMP-2 (Infuse) or other active biologics * Active or systemic infection, malignancy, or severe metabolic bone disease * Chronic steroid use (\>10 days) * Revision fusion at index levels * Participation in another interventional clinical study within 30 days of consent * Known pregnancy or intent to become pregnant during the study

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder lumbar spinal stenosis spinal stenosis spondylolisthesis

As listed by the trial registrant

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

Degenerative disc disease Lumbar spine fusion Spinal stenosis lumbar Spinal stenosis, lumbar region Spondylolisthesis Transforaminal lumbar interbody fusion

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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