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COMPLETEDPHASE2

Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion

A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Lumbar Interbody Fusion With Instrumentation

NCT00996073•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) in 1 or 2 adjacent vertebral levels between L1 and S1. All subjects in this study will undergo interbody fusion via Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior instrumentation.

Detailed Description

This is a prospective, multicenter, randomized, open-label controlled Phase 2 study designed to evaluate the safety and preliminary efficacy of adult, allogeneic mesenchymal precursor cells (MPCs) combined with MasterGraft Matrix when compared to use of autologous iliac crest bone graft in the lumbar interbody fusion site in subjects requiring 1 or 2 level interbody fusion procedure with instrumentation. All subjects in this study will undergo a 1 or 2-level (2 or 3 vertebrae) interbody fusion with supplemental posterior instrumentation. 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, 9, 12, 24, and 36 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 at least 18 years of age, but not older than 70.
•2. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
•3. Have 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. Have a documented symptomatic diagnosis of DDD at L1-S1 with or without stenosis and with or without up to and including Grade II degenerative spondylolisthesis.
•5. Have clinical symptoms of neurogenic claudication.
•6. Have failed 6 months of non-operative low back pain management.
•7. Are candidates for posterior lumbar interbody fusion in combination with posterior pedicle screw stabilization and require surgery at a 1 or 2 adjacent vertebral levels between L1 and S1.
•8. Have 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.
•* Male subjects with partners of childbearing potential must agree to use adequate contraception (barrier method or abstinence) from the time of surgery and for a period of at least 1 year after surgery.
•2. Have 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. Have 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.
•4. Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
•5. Have a positive screen for human immunodeficiency virus (HIV) antibodies.
•6. Have 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 3-year follow-up period.
•7. Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
•8. Have a body mass index (BMI) \> 35.
•9. Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
+1 more criteria

Locations (5)

The Spine Institute

Santa Monica, California, United States

Denver Spine

Greenwood Village, Colorado, United States

Rocky Mountain Associates in Orthopedic Medicine, P.C.

Loveland, Colorado, United States

Fort Wayne Orthopaedics

Fort Wayne, Indiana, United States

Central Texas Spine Institute

Austin, Texas, United States

Key Dates

Start Date

September 1, 2009

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2014

Last Updated

June 29, 2020

Enrollment

ACTUAL participants

Conditions

Degenerative Disc DiseaseDegenerative SpondylolisthesisSpinal Stenosis

Interventions

Lumbar Interbody Fusion with Autograft

BIOLOGICAL

Lumbar Interbody Fusion with NeoFuse

BIOLOGICAL

Lumbar Interbody Fusion with NeoFuse

BIOLOGICAL

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

NCT04992572

Lumbar Spinal Stenosis

View study

RECRUITINGPHASE3

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

NCT07254806

Degenerative Disc Disease

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RECRUITING

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

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: June 29, 2020Data 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.

View ClinicalTrials.gov Terms and Conditions

Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring 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