Subjects Treated With NMP as Part of Their Spine SurgeryNCT06971835
INDUCE: A Prospective 2-Year Spine Registry
An observational study of Subjects Treated With NMP as Part of Their Spine Surgery and Degenerative Disc Disease (DDD), run by Red Rock Regeneration Inc. at 3 sites in United States.
Trial summary
The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
- What is being tested?
- NMP
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Feb 2026to Jan 2029
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study will include a maximum of 10 US sites, covering a large geographic region, representing a diverse demographic cohort.
Who may be able to join
- 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
- 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.
- Skeletally mature (age≥18 years of age)
- Be willing to sign the study-specific informed consent document prior to index surgery
Who cannot join
- Not willing to sign the study-specific informed consent document prior to index surgery
- Use of allogenic growth factor extacts (i.e. OsteoFactor/ProteiOS), Demineralized Bone Matrix (DBM), or cell based allografts as part of the index surgery (use of autograft or bone marrow aspirate (BMA) is allowed)
- Use of rhBMP-2 (i.e. INFUSE) or synthetic peptide enhanced graft (i.e. iFactor) as part of the index surgery
- Diagnosis of spinal deformity (greater than 20 degrees) or vertebral fracture including treated level
- Unable to comply with postoperative standard of care imaging (e.g. pregnant or nursing female)
- Did not complete baseline patient reported outcomes prior to index surgery
- Incarcerated at the time of surgery or preoperative evaluation
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Spine Center of Louisiana
Baton Rouge, Louisiana, 70809
Huntsman Spinal Clinic
Salt Lake City, Utah, 84124
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
About this study
Official title: Assessment of Safety and Clinical Effectiveness of Induce NMP® in Degenerative Spine Surgery: A Prospective 2-Year Registry
The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lumbar spine.
The secondary objective is to assess patient reported outcomes following the use of NMP in the treatment of the spine.
Read the detailed description
This is a multicenter, observational, prospective registry study of up to 1,000 patients across a maximum of 10 US sites. All subjects who meet study entrance criteria and planned to be treated with NMP Fibers and/or Micro Particulates as part of their cervical or lumbar spinal surgery will be invited to participate in the study.
PRIMARY ENDPOINTS
- Safety - freedom from product-related serious adverse events and subsequent surgical interventions at the treated level(s)
- Effectiveness - presence of fusion as measured by x-rays and if available CT.
SECONDARY ENDPOINTS
Beyond the primary endpoints, the following data may be collected and analyzed including, but not limited to, the following variables:
- Baseline demographics and medical history
- Duration of hospitalization
- Operative time
- Estimated blood loss
- Neurological status
- Subject patient reported outcomes as applicable including, but not limited to:
- Oswestry Disability Index (ODI)/ Neck Disability Index (NDI)
- Visual Analog Scale (VAS) Pain
- Veteran Rand 12-Item Health Survey (VR-12)
- Being tested
- NMP
- Keywords
- degenerative spine, NMP, Induce
- 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.
NMPDevice
The study product is Induce Biologics NMP Fibers and NMP Micro Particulates however, this is observational research that involves standard of care.
NMP is regulated as a human cellular or tissue-based product (HCT/P) under section 361 of the Public Health Service (PHS) Act and in 21 CFR Part 1271. Under this regulation it did not require clinical evaluation before it could be used commercially. It is indicated for use "as a bone void filler for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the boney structure.
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated on-label with NMP as part of their spine surgery. | Subjects 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. Receives: Device: NMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Incidence of fusion at treated levels as measured by x-rays and if available CT, will be reported.
Measured: 6 month and 12 month post surgery, and 24 month post surgery
Serious Adverse Events and Subsequent Surgical Interventions
Incidence of serious adverse events (SAE) and subsequent surgical intervention (SSI) will be reported.
Measured: Through study completion, an average of 2 years.
Secondary outcomes (3)
Change in Pain
Pain scores will be reported as assessed by Visual Analog Scale scores, (0-100mm) or Numeric Rating Scale (0-10) depending on institutions standard of care. Higher score indicates increased pain.
Measured: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Change in Disability
Disability improvement as measured by Oswestry Disability Index (ODI) or Neck Disability Index (NDI), as applicable, 0-100%. High score indicates increase disability.
Measured: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Change in Quality of Life
Improvement in qualify of life as measured by Veterans Rand-12, 0-100. High score indicates increase quality of life.
Measured: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start17 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Treated With NMP as Part of Their Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Red Rock Regeneration Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971835
- Sponsor's protocol ID
- CT-NMP-009
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Clinical Effectiveness of Induce NMP® in Degenerative Spine Surgery: A Prospective 2-Year Registry
- ClinicalTrials.gov ID
- NCT06971835
- Acronym / sponsor ID
- CT-NMP-009
- Keywords
- degenerative spine, NMP, Induce
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Red Rock Regeneration Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of Natural Matrix Protein® (NMP®) when used to promote fusion in the cervical or lumbar spine.
The secondary objective is to assess patient reported outcomes following the use of NMP in the treatment of the spine.
Detailed description
This is a multicenter, observational, prospective registry study of up to 1,000 patients across a maximum of 10 US sites. All subjects who meet study entrance criteria and planned to be treated with NMP Fibers and/or Micro Particulates as part of their cervical or lumbar spinal surgery will be invited to participate in the study.
PRIMARY ENDPOINTS
- Safety - freedom from product-related serious adverse events and subsequent surgical interventions at the treated level(s)
- Effectiveness - presence of fusion as measured by x-rays and if available CT.
SECONDARY ENDPOINTS
Beyond the primary endpoints, the following data may be collected and analyzed including, but not limited to, the following variables:
- Baseline demographics and medical history
- Duration of hospitalization
- Operative time
- Estimated blood loss
- Neurological status
- Subject patient reported outcomes as applicable including, but not limited to:
- Oswestry Disability Index (ODI)/ Neck Disability Index (NDI)
- Visual Analog Scale (VAS) Pain
- Veteran Rand 12-Item Health Survey (VR-12)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated on-label with NMP as part of their spine surgery. | – | Device: NMPSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study will include a maximum of 10 US sites, covering a large geographic region, representing a diverse demographic cohort.
Key inclusion criteria (4 listed)
- 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
- 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.
- Skeletally mature (age≥18 years of age)
- Be willing to sign the study-specific informed consent document prior to index surgery
Key exclusion criteria (7 listed)
- Not willing to sign the study-specific informed consent document prior to index surgery
- Use of allogenic growth factor extacts (i.e. OsteoFactor/ProteiOS), Demineralized Bone Matrix (DBM), or cell based allografts as part of the index surgery (use of autograft or bone marrow aspirate (BMA) is allowed)
- Use of rhBMP-2 (i.e. INFUSE) or synthetic peptide enhanced graft (i.e. iFactor) as part of the index surgery
- Diagnosis of spinal deformity (greater than 20 degrees) or vertebral fracture including treated level
- Unable to comply with postoperative standard of care imaging (e.g. pregnant or nursing female)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMPThe study product is Induce Biologics NMP Fibers and NMP Micro Particulates however, this is observational research that involves standard of care. NMP is regulated as a human cellular or tissue-based product (HCT/P) under section 361 of the Public Health Service (PHS) Act and in 21 CFR Part 1271. Under this regulation it did not require clinical evaluation before it could be used commercially. It is indicated for use "as a bone void filler for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the boney structure. | Device | Subjects treated on-label with NMP as part of their spine surgery. |
Primary outcome
Fusion
Time frame: 6 month and 12 month post surgery, and 24 month post surgery
Incidence of fusion at treated levels as measured by x-rays and if available CT, will be reported.
Serious Adverse Events and Subsequent Surgical Interventions
Time frame: Through study completion, an average of 2 years.
Incidence of serious adverse events (SAE) and subsequent surgical intervention (SSI) will be reported.
3 secondary outcomes
Change in Pain
Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Change in Disability
Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Change in Quality of Life
Time frame: Baseline, 3 month, 6 months, 12 months, and 24 months postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjects Treated With NMP as Part of Their Spine Surgery and Degenerative Disc Disease (DDD), run by Red Rock Regeneration Inc. at 3 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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion (time frame: 6 month and 12 month post surgery, and 24 month post surgery). 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?
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 19 Oct 2026.