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

October 9, 2009
March 11, 2014
September 2009
July 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00996073 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Spinal Stenosis
  • Biological: Lumbar Interbody Fusion with Autograft
    Single Dose Autograft Surgical Implantation
    Other Names:
    • Spinal Fusion
    • Control
  • Biological: Lumbar Interbody Fusion with NeoFuse
    Single Dose NeoFuse Surgical Implantation
    Other Names:
    • Spinal Fusion
    • Stem Cells
  • Active Comparator: Autograft
    Lumbar Interbody Fusion with Autograft
    Intervention: Biological: Lumbar Interbody Fusion with Autograft
  • Experimental: Low Dose
    Lumbar Interbody Fusion with NeoFuse-Low Dose
    Intervention: Biological: Lumbar Interbody Fusion with NeoFuse
  • Experimental: High Dose
    Lumbar Interbody Fusion with NeoFuse-High Dose
    Intervention: Biological: Lumbar Interbody Fusion with NeoFuse
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00996073
MSB-SF003
Yes
Mesoblast, Ltd.
Mesoblast, Ltd.
Not Provided
Study Director: Roger Brown Senior Vice President of Musculoskeletal Repair
Mesoblast, Ltd.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP