Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion

Study Purpose

The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Have clinical or radiological evidence of degenerative disc disease of the lumbar spine. 2. Have been treated with Induce Biologics NMP™ during a lumbar spinal fusion procedure. 3. Be at least 18 years of age. 4. Have current contact information. 5. Be willing and able to provide written Informed Consent for the prospective part of study participation. 6. Be willing and able to undergo a CT-scan and X-rays. 7. Be willing and able to complete patient centered outcome questionnaires.

Exclusion Criteria:

1. Currently imprisoned. 2. 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. X-rays or CT-scan are contraindicated. 4. Any previous lumbar fusion or arthroplasty surgery at the index level(s)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05972616
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Induce Biologics USA Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pierce Nunley, MD
Principal Investigator Affiliation	Spine Institute of Louisiana
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Degenerative Disc Disease

Additional Details

The study involves a retrospective review of patients' medical records and prospective collection of CT scans, X-rays, and patient centered outcome questionnaires. The study population will include up to 135 patients of the Spine Institute of Louisiana (SIL) who have been treated with Induce Biologics NMP™ during a lumbar interbody fusion. All subjects who meet all inclusion criteria and do not meet any exclusion criteria will be included in the study. There will be a single Prospective Visit in this study. This visit will be scheduled at the 12-month (± 2 mo) post-surgery time point.

Arms & Interventions

Arms

: NMP

Have clinical or radiological evidence of degenerative disc disease of the lumbar spine. Have been treated with NMP™ during a lumbar spinal fusion procedure.

Interventions

Biological: - Natural Matrix Protein (NMP)

human bone allograft

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Spine Institute of Louisiana, Shreveport, Louisiana

Status

Address

Spine Institute of Louisiana

Shreveport, Louisiana, 71101

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