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

Tracking Information
First Submitted Date ICMJE	October 9, 2009
First Posted Date ICMJE	October 16, 2009
Last Update Posted Date	December 19, 2016
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	July 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 15, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00996073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 15, 2009)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
Official Title ICMJE	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
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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Degenerative Disc Disease; Degenerative Spondylolisthesis; Spinal Stenosis
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 15, 2009)	24
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2014
Actual Primary Completion Date	July 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male or females at least 18 years of age, but not older than 70.; Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.; 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].; 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.; Have clinical symptoms of neurogenic claudication.; Have failed 6 months of non-operative low back pain management.; 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.; Have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery. Exclusion Criteria: 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.; 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.; 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.; Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.; Have a positive screen for human immunodeficiency virus (HIV) antibodies.; 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.; Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.; Have a body mass index (BMI) > 35.; Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.; 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00996073
Other Study ID Numbers ICMJE	MSB-SF003
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mesoblast, Ltd.
Study Sponsor ICMJE	Mesoblast, Ltd.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Roger Brown Senior Vice President of Musculoskeletal Repair
PRS Account	Mesoblast, Ltd.
Verification Date	December 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP