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New bone graft material under scrutiny in 1,000-Patient spine study

NCT ID NCT06971835

Disease control Sponsor: Red Rock Regeneration 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking 1,000 people who received a bone graft material called Natural Matrix Protein (NMP) during spine surgery for degenerative disc disease. Researchers will monitor bone fusion, pain, and disability over two years to see if NMP is safe and helps the spine heal. Participants are already receiving NMP as part of their standard care, and this registry simply observes their outcomes.

What this could mean

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

Active substance
Natural Matrix Protein (NMP) fibers and micro particulates, a bone graft material
What this could lead to
If successful, this could confirm that NMP is a safe and effective option to help bones fuse in spine surgery, potentially improving pain and disability outcomes.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less reliable. It is also early-stage evidence for a product already in use, and individual results may vary.

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.

Participants

About 1,000 people

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

Started

Feb 2026

Expected to finish

Jan 2029

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.

Who is studied

Study will include a maximum of 10 US sites, covering a large geographic region, representing a diverse demographic cohort.

Ages

18 years and older

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: 1. Implanted on-label with NMP in at least one vertebral level in the cervical (C1-C7) or lumbar (L1-S1) spine as part of their surgery 2. Total volume of bone graft or bone graft substitute used in index surgery must contain at least 50% NMP by volume per treated level, where NMP is mixed with other graft material. 3. Skeletally mature (age≥18 years of age) 4. Be willing to sign the study-specific informed consent document prior to index surgery Exclusion Criteria: 1. Not willing to sign the study-specific informed consent document prior to index surgery 2. Use of allogenic growth factor extacts (i.e. OsteoFactor/ProteiOS) or cell based allografts as part of the index surgery (use of autograft or bone marrow aspirate (BMA) is allowed) 3. Use of rhBMP-2 (i.e. INFUSE) or synthetic peptide enhanced graft (i.e. iFactor) as part of the index surgery 4. Diagnosis of spinal deformity (greater than 20 degrees) or vertebral fracture including treated level 5. Unable to comply with postoperative standard of care imaging (e.g. pregnant or nursing female) 6. Did not complete baseline patient reported outcomes prior to index surgery 7. Incarcerated at the time of surgery or preoperative evaluation

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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 (DDD) Subjects treated with NMP as part of their spine surgery

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

    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 ↗

  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

  • Spine Center of Louisiana

    Baton Rouge, Louisiana, 70809, United States

  • Spine Institute of Louisiana

    Shreveport, Louisiana, 71101, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.