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Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy

Phase 2 Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion With Anterior Cervical Plate Fixation

NCT01097486•Mesoblast, Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.

Detailed Description

This is a prospective, multicenter, randomized, single-blinded, controlled study evaluating safety and preliminary efficacy of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Matrix in a commercially available PEEK cervical spacer compared to a cervical Allograft Spacer control in subjects undergoing 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation. After the screening and surgical visits, each subject will be evaluated clinically and radiographically within 3 days and 30 days after surgery, and at 3, 6, 12, and 24 months after surgery. Subjects will be evaluated at the same time points for safety.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or females between 18 and 70 years of age, inclusive.
•2. Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
•3. Has the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) \[per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US\].
•4. Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1.
•5. Has symptomatic radiculopathy and/or myelopathy correlating to radiographic findings of duration of 6 weeks or greater that had failed to respond to non-operative management
•6. Is a candidate for anterior cervical discectomy and fusion in two or three adjacent cervical interbody levels between C3-C4 to C7-T1
•7. Has a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.

Exclusion Criteria

•1. Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
•2. Has a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening.
•3. Has at the time of surgery a systemic or local infection at the site of proposed surgery.
•4. Has or is undergoing revision of a prior fusion surgery at any involved level.
•5. Requires ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
•6. Requires ACDF without the use of an anterior cervical plating system.
•7. Has osteoporosis as defined by a DEXA T score of ≤ -3.0 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
•8. Has a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
•9. Has a positive screen for human immunodeficiency virus (HIV) antibodies.
•10. has had treatment with any investigational therapy or device within 6 months of study surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 2-year follow-up period.
+3 more criteria

Locations (8)

UC Davis Spine Center

Sacramento, California, United States

The Spine Institute

Santa Monica, California, United States

Denver Spine

Denver, Colorado, United States

Rocky Mountain Associates in Orthopedic Medicine, P.C.

Loveland, Colorado, United States

Tallahassee Neurological Clinic, P.A.

Tallahassee, Florida, United States

Fort Wayne Orthopaedics

Fort Wayne, Indiana, United States

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, United States

Central Texas Spine Institute

Austin, Texas, United States

Key Dates

Start Date

June 1, 2010

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2014

Last Updated

August 16, 2019

Enrollment

ACTUAL participants

Conditions

Cervical Degenerative Disc DiseaseDegenerative SpondylolisthesisSpinal Stenosis

Interventions

NeoFuse

BIOLOGICAL

Allograft

PROCEDURE

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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: August 16, 2019Data 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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Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy

Inclusion Criteria

Exclusion Criteria

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