NCT01097486

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) 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.

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 Jun 2010

Typical duration for phase_2

Geographic Reach
1 country

8 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

First Submitted

Initial submission to the registry

March 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 16, 2019

Status Verified

December 1, 2016

Enrollment Period

3.1 years

First QC Date

March 30, 2010

Last Update Submit

August 14, 2019

Conditions

Cervical Degenerative Disc DiseaseDegenerative SpondylolisthesisSpinal Stenosis

Keywords

Cervical Degenerative Disc DiseaseDegenerative SpondylolisthesisSpinal StenosisStem cellsAdult Stem CellsAnterior cervical discectomy and Fusion (ACDF)Cervical Allograft SpacerAnterior Cervical Plate Fixation

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (1)

  • To evaluate the fusion success with NeoFuse compared to allograft spacer using CT scans and x-ray of the involved cervical spine levels and assess the change in outcomes (NDI, SF-36, Zung Depression Questionnaire, and WPAI.

    1 years

Study Arms (2)

Allograft

ACTIVE COMPARATOR

Cervical Spinal Fusion with Allograft

Procedure: Allograft

NeoFuse

EXPERIMENTAL

Cervical Spinal Fusion with NeoFuse

Biological: NeoFuse

Interventions

NeoFuseBIOLOGICAL

Single Dose NeoFuse Surgical Implantation

Also known as: Anterior Cervical Discectomy and Fusion with NeoFuse, Cervical Spinal Fusion, Stem Cells
NeoFuse
AllograftPROCEDURE

Single Dose Allograft Surgical Implantation

Also known as: Anterior Cervical Discectomy and Fusion with Allograft, Cervical Spinal Fusion, Control
Allograft

Eligibility Criteria

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

You may qualify if:

  • Male or females between 18 and 70 years of age, inclusive.
  • Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
  • Has the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) \[per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US\].
  • Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1.
  • 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
  • Is a candidate for anterior cervical discectomy and fusion in two or three adjacent cervical interbody levels between C3-C4 to C7-T1
  • Has 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.
  • 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.
  • Has at the time of surgery a systemic or local infection at the site of proposed surgery.
  • Has or is undergoing revision of a prior fusion surgery at any involved level.
  • Requires ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
  • Requires ACDF without the use of an anterior cervical plating system.
  • 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.
  • Has a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
  • Has a positive screen for human immunodeficiency virus (HIV) antibodies.
  • 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.
  • Has been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
  • Has 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
  • Is 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 (8)

UC Davis Spine Center

Sacramento, California, 95816, United States

Location

The Spine Institute

Santa Monica, California, 90403, United States

Location

Denver Spine

Denver, Colorado, 80111, United States

Location

Rocky Mountain Associates in Orthopedic Medicine, P.C.

Loveland, Colorado, 80538, United States

Location

Tallahassee Neurological Clinic, P.A.

Tallahassee, Florida, 32308, United States

Location

Fort Wayne Orthopaedics

Fort Wayne, Indiana, 46804, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Central Texas Spine Institute

Austin, Texas, 78705, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Gene FusionTransplantation, Homologous

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic PhenomenaTransplantationSurgical Procedures, Operative

Study Officials

  • Roger Brown

    Mesoblast, Ltd.

    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

March 30, 2010

First Posted

April 1, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2014

Last Updated

August 16, 2019

Record last verified: 2016-12

Locations

US(8)