NCT00996073

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

2.8 years

First QC Date

October 9, 2009

Last Update Submit

June 25, 2020

Conditions

Degenerative Disc DiseaseDegenerative SpondylolisthesisSpinal Stenosis

Keywords

Degenerative disc diseaseSpondylolisthesisSpinal stenosisStem cellsAdult Stem CellsSpinal FusionLumbar Spinal FusionTLIFPLIFMesoblast

Outcome Measures

Primary Outcomes (1)

  • To determine the overall safety of NeoFuse plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).

    3 years

Secondary Outcomes (1)

  • To evaluate the overall fusion success with NeoFuse plus carrier compared to autograft using CT scans and x-ray of the involved lumbar spine levels and assess the change in outcomes (ODI, SF-36, and WPAI) and pain (VAS)at the 12-month follow-up visit.

    3 years

Study Arms (3)

Autograft

ACTIVE COMPARATOR

Lumbar Interbody Fusion with Autograft

Biological: Lumbar Interbody Fusion with Autograft

Low Dose

EXPERIMENTAL

Lumbar Interbody Fusion with NeoFuse-Low Dose

Biological: Lumbar Interbody Fusion with NeoFuse

High Dose

EXPERIMENTAL

Lumbar Interbody Fusion with NeoFuse-High Dose

Biological: Lumbar Interbody Fusion with NeoFuse

Interventions

Lumbar Interbody Fusion with AutograftBIOLOGICAL

Single Dose Autograft Surgical Implantation

Also known as: Spinal Fusion, Control
Autograft
Lumbar Interbody Fusion with NeoFuseBIOLOGICAL

Single Dose NeoFuse Surgical Implantation

Also known as: Spinal Fusion, Stem Cells
Low Dose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or females at least 18 years of age, but not older than 70.
  • Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
  • Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) \[per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US\].
  • 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.
  • Have clinical symptoms of neurogenic claudication.
  • Have failed 6 months of non-operative low back pain management.
  • 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.
  • Have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.

You may not qualify if:

  • 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.
  • 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.
  • 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.
  • Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
  • Have a positive screen for human immunodeficiency virus (HIV) antibodies.
  • 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.
  • Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
  • Have a body mass index (BMI) \> 35.
  • Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
  • Are transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Spine Institute

Santa Monica, California, 90404, United States

Location

Denver Spine

Greenwood Village, Colorado, 80111, United States

Location

Rocky Mountain Associates in Orthopedic Medicine, P.C.

Loveland, Colorado, 80538, United States

Location

Fort Wayne Orthopaedics

Fort Wayne, Indiana, 46804, United States

Location

Central Texas Spine Institute

Austin, Texas, 78731, United States

Location

Related Links

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal StenosisSpondylolisthesis

Interventions

Transplantation, AutologousSpinal Fusion

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, OperativeArthrodesisOrthopedic Procedures

Study Officials

  • Roger Brown

    Senior Vice President of Musculoskeletal Repair

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 16, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2014

Last Updated

June 29, 2020

Record last verified: 2020-06

Locations

US(5)