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

Completed · Phase 2

Conditions studied: Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis

In brief

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.

Key facts

Study ID: NCT00996073
Run by: Mesoblast, Ltd.
People needed: 24
Starts: 2009-09-01
Expected to finish: 2014-07-01
Last updated by the study team: 2020-06-29

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].
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.

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.
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.

Where it is running

The Spine Institute — Santa Monica, California, United States
Denver Spine — Greenwood Village, Colorado, United States
Rocky Mountain Associates in Orthopedic Medicine, P.C. — Loveland, Colorado, United States
Fort Wayne Orthopaedics — Fort Wayne, Indiana, United States
Central Texas Spine Institute — Austin, Texas, United States

Full record on ClinicalTrials.gov

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