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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01097486
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : August 16, 2019
Information provided by (Responsible Party):
Mesoblast, Ltd.

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.

Condition or disease Intervention/treatment Phase
Cervical Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis Biological: NeoFuse Procedure: Allograft Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Allograft
Cervical Spinal Fusion with Allograft
Procedure: Allograft
Single Dose Allograft Surgical Implantation
Other Names:
  • Anterior Cervical Discectomy and Fusion with Allograft
  • Cervical Spinal Fusion
  • Control

Experimental: NeoFuse
Cervical Spinal Fusion with NeoFuse
Biological: NeoFuse
Single Dose NeoFuse Surgical Implantation
Other Names:
  • Anterior Cervical Discectomy and Fusion with NeoFuse
  • Cervical Spinal Fusion
  • Stem Cells

Primary Outcome Measures :
  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). [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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. [ Time Frame: 1 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  11. Has been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
  12. Has 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
  13. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01097486

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United States, California
UC Davis Spine Center
Sacramento, California, United States, 95816
The Spine Institute
Santa Monica, California, United States, 90403
United States, Colorado
Denver Spine
Denver, Colorado, United States, 80111
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States, 80538
United States, Florida
Tallahassee Neurological Clinic, P.A.
Tallahassee, Florida, United States, 32308
United States, Indiana
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States, 46804
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28204
United States, Texas
Central Texas Spine Institute
Austin, Texas, United States, 78705
Sponsors and Collaborators
Mesoblast, Ltd.
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Study Director: Roger Brown Mesoblast, Ltd.
Additional Information:
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Responsible Party: Mesoblast, Ltd. Identifier: NCT01097486    
Other Study ID Numbers: MSB-CF002
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: December 2016
Keywords provided by Mesoblast, Ltd.:
Cervical Degenerative Disc Disease
Degenerative Spondylolisthesis
Spinal Stenosis
Stem cells
Adult Stem Cells
Anterior cervical discectomy and Fusion (ACDF)
Cervical Allograft Spacer
Anterior Cervical Plate Fixation
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases