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Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

Prospective Evaluation of Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

NCT06000319•Induce Biologics USA Inc.

Summary

The aim of this study is to evaluate the effectiveness and safety of Natural Matrix Protein™ (NMP™) fibers when used in cervical or lumbar interbody fusion in patients with degenerative disc disease (DDD), spinal stenosis, spondylolisthesis undergoing cervical or lumbar interbody spine fusion at no more than 3 adjacent levels.

Detailed Description

The study involves a retrospective review of patients' medical records and prospective collection of X-rays, and patient outcome questionnaires. The study population will include 100 consecutive lumbar interbody fusion and 100 consecutive cervical interbody fusion patients who meet the inclusion criteria and do not meet the exclusion criteria. There will be 4 prospective study visits following consent. Follow-up will occur in accordance with standard of care practice and will continue to 12 months post-surgery

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject was diagnosed with DDD, spinal stenosis, or spondylolisthesis;
•2. Subject has undergone cervical or lumbar interbody spine fusion at no more than 3 adjacent levels between C2 and T1 or between L1 and S1;
•3. Subject has undergone cervical or lumbar interbody spine fusion using NMP Fibers;
•4. Subject must be 18 years of age or older at the time of consent;
•5. Subject must be willing and able to sign an informed consent document;
•6. Subject must be willing and able to return to the study clinic for all follow-up visits, agree to participate in post-operative clinical and radiographic evaluations.

Exclusion Criteria

•1. Subject is under 18 years of age at the time of consent;
•2. Subject is currently experiencing major mental illness (psychosis, schizophrenia, major affective disorder) which in the opinion of the investigator may indicate that the symptoms are psychological rather than of physical origin;
•3. Subject is currently imprisoned.

Locations (1)

Alabama Back Institute

Jasper, Alabama, United States

Key Dates

Start Date

January 4, 2024

Primary Completion Date

February 1, 2027

Completion Date

August 1, 2027

Last Updated

November 18, 2025

Enrollment

200

ESTIMATED participants

Conditions

Degenerative Disc DiseaseDegenerative SpondylolisthesisSpinal Stenosis

Interventions

Natural Matrix Protein (NMP) Fibers

BIOLOGICAL

Lumbar interbody fusion

PROCEDURE

Cervical interbody fusion

PROCEDURE

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion

Inclusion Criteria

Exclusion Criteria

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

Multicentric Case Series of Uniportal Endoscopic Posterior Cervical Decompression for Cervical Spinal Stenosis

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery