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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT01106417
First received: April 16, 2010
Last updated: March 11, 2014
Last verified: August 2012
  Purpose

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 Intervention Phase
Cervical Degenerative Disc Disease
Degenerative Spondylolisthesis
Spinal Stenosis
Procedure: NeoFuse
Procedure: MasterGraft Granules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • Safety of NeoFuse [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Fusion success with NeoFuse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To evaluate the fusion success with NeoFuse compared to an active control 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.


Estimated Enrollment: 12
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeoFuse
Anterior Cervical Discectomy and Fusion with NeoFuse
Procedure: NeoFuse
Single Dose NeoFuse Surgical Implantation
Other Names:
  • Anterior Cervical Discectomy and Fusion with NeoFuse
  • Cervical Spinal Fusion
  • Adult Stem Cells
Active Comparator: MasterGraft Granules
Anterior Cervical Discectomy and Fusion with MasterGraft Granules
Procedure: MasterGraft Granules
Single Dose MaterGraft Granules Surgical Implantation
Other Names:
  • Anterior Cervical Discectomy and Fusion with Granules
  • Cervical Spinal Fusion
  • Active Control

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 an active 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106417

Locations
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Mesoblast, Ltd.
Investigators
Study Director: Roger Brown Mesoblast, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT01106417     History of Changes
Other Study ID Numbers: MSB-CF001
Study First Received: April 16, 2010
Last Updated: March 11, 2014
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by Mesoblast, Ltd.:
Cervical Degenerative Disc Disease
Degenerative Spondylolisthesis
Spinal Stenosis
Stem cells
Adult Stem Cells
Anterior cervical discectomy and Fusion (ACDF)
Anterior Cervical Plate Fixation

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Diseases
Spinal Stenosis
Spondylolisthesis
Intervertebral Disk Degeneration
Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on July 20, 2014