Status:
WITHDRAWN
Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion
Lead Sponsor:
Mesoblast, Ltd.
Conditions:
Degenerative Disc Disease
Degenerative Spondylolisthesis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
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 compare...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00810212
Start Date
November 1 2008
End Date
November 1 2011
Last Update
June 2 2020
Active Locations (1)
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1
Texas Back Institute
Plano, Texas, United States, 75093