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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT00996073
First received: October 9, 2009
Last updated: March 11, 2014
Last verified: September 2013
  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) 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.


Condition Intervention Phase
Degenerative Disc Disease
Degenerative Spondylolisthesis
Spinal Stenosis
Biological: Lumbar Interbody Fusion with Autograft
Biological: Lumbar Interbody Fusion with NeoFuse
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: 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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:
  • 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). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Autograft
Lumbar Interbody Fusion with Autograft
Biological: Lumbar Interbody Fusion with Autograft
Single Dose Autograft Surgical Implantation
Other Names:
  • Spinal Fusion
  • Control
Experimental: Low Dose
Lumbar Interbody Fusion with NeoFuse-Low Dose
Biological: Lumbar Interbody Fusion with NeoFuse
Single Dose NeoFuse Surgical Implantation
Other Names:
  • Spinal Fusion
  • Stem Cells
Experimental: High Dose
Lumbar Interbody Fusion with NeoFuse-High Dose
Biological: Lumbar Interbody Fusion with NeoFuse
Single Dose NeoFuse Surgical Implantation
Other Names:
  • Spinal Fusion
  • Stem Cells

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

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 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.
  10. 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.
  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: NCT00996073

Locations
United States, California
The Spine Institute
Santa Monica, California, United States, 90404
United States, Colorado
Denver Spine
Greenwood Village, Colorado, United States, 80111
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States, 80538
United States, Indiana
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States, 46804
United States, Texas
Central Texas Spine Institute
Austin, Texas, United States, 78731
Sponsors and Collaborators
Mesoblast, Ltd.
Investigators
Study Director: Roger Brown Senior Vice President of Musculoskeletal Repair
  More Information

Additional Information:
No publications provided

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT00996073     History of Changes
Other Study ID Numbers: MSB-SF003
Study First Received: October 9, 2009
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mesoblast, Ltd.:
Degenerative disc disease
Spondylolisthesis
Spinal stenosis
Stem cells
Adult Stem Cells
Spinal Fusion
Lumbar Spinal Fusion
TLIF
PLIF
Mesoblast

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

ClinicalTrials.gov processed this record on August 20, 2014