Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion - Full Text View

Sponsored by:	Mesoblast, Ltd.
Information provided by:	Mesoblast, Ltd.
ClinicalTrials.gov Identifier:	NCT00810212

Purpose

The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing posterolateral lumbar fusion.

Condition	Intervention	Phase
Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis	Procedure: PLF with autograft Genetic: PLF with NeoFuse	Phase I Phase II

MedlinePlus related topics: Spinal Stenosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title:	A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With Mastergraft Granules in Subjects Undergoing Posterolateral Lumbar Fusion With Instrumentation

Further study details as provided by Mesoblast, Ltd.:

Primary Outcome Measures:

To determine the safety of NeoFuse (allogeneic mesenchymal precursor cells [MPCs] when combined with MasterGraft Resorbable Ceramic granules as a carrier for posterolateral lumbar fusion (PLF) with instrumentation [ 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 access the change in outcomes (ODI, SF-36) and pain (VAS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Autograft	Procedure: PLF with autograft 6 subjects
2: Experimental Low Dose	Genetic: PLF with NeoFuse 6 subjects low dose
3: Experimental Medium Dose	Genetic: PLF with NeoFuse 6 subjects medium dose
4: Experimental High Dose	Genetic: PLF with NeoFuse 6 subjects high dose

Detailed Description:

This is a prospective, multicenter, randomized, open-label controlled Phase 1b/2a study designed to evaluate the safety and preliminary efficacy of MPCs combined with MasterGraft Granules when compared to use of autologous bone graft in the posterolateral fusion site in subjects requiring interbody fusion in combination with instrumented 1 or 2 level PLF procedure. All subjects in this study will undergo a 1 or 2-level (2 or 3 vertebrae) interbody fusion without the use of the investigational product.

In addition to the interbody fusion procedure, subjects will undergo an instrumented posterolateral fusion. NeoFuse plus MasterGraft Granules at one of three doses or autograft will be implanted in the posterolateral lumbar fusion site(s) only.

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, and 12 months after surgery.

Subjects will be evaluated at 24 and 36 months after surgery for safety.

Eligibility

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

Criteria

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 or applicable regulations outside 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 lumbar interbody fusion with autograft in combination with posterolateral fusion 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.
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 ≤ -3.5 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.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810212

Locations

United States, Texas
Texas Back Institute	Recruiting
Plano, Texas, United States, 75093
Contact: Vickie Arford, RN varford@spinemarkcro.com
Principal Investigator: Richard Guyer, MD

Sponsors and Collaborators

Mesoblast, Ltd.

Investigators

Principal Investigator:

Donna Skerrett, MD

Mesoblast, Ltd., c/o Angioblast Systems, Inc.

More Information

Responsible Party:	Mesoblast, Ltd., c/o Angioblast Systems, inc. ( Donna Skerrett, MD, Medical Officer )
Study ID Numbers:	MSB-SF002
Study First Received:	December 17, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00810212
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mesoblast, Ltd.:

Degenerative disc disease
Spondylolisthesis
Spinal stenosis
Stem cell
Spinal Fusion

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Constriction, Pathologic

Spondylolisthesis
Bone Diseases
Spinal Stenosis

ClinicalTrials.gov processed this record on January 14, 2009