Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
In brief
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.
Key facts
- Study ID
- NCT00810212
- Run by
- Mesoblast, Ltd.
- People needed
- 0
- Starts
- 2008-11-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2020-06-02
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 -
You may not qualify if…
- 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.
Where it is running
- Texas Back Institute — Plano, Texas, United States
- Texas Back Institute — Plano, Texas, United States
Full record on ClinicalTrials.gov
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