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

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: NCT00996073
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : June 29, 2020
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) 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 or disease Intervention/treatment Phase
Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis Biological: Lumbar Interbody Fusion with Autograft Biological: Lumbar Interbody Fusion with NeoFuse Phase 2

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.

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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: 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
Study Start Date : September 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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). [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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. [ Time Frame: 3 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 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.

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): NCT00996073

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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.
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Study Director: Roger Brown Senior Vice President of Musculoskeletal Repair
Additional Information:
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Responsible Party: Mesoblast, Ltd. Identifier: NCT00996073    
Other Study ID Numbers: MSB-SF003
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Keywords provided by Mesoblast, Ltd.:
Degenerative disc disease
Spinal stenosis
Stem cells
Adult Stem Cells
Spinal Fusion
Lumbar Spinal Fusion
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases