Study of the ReGelTec HYDRAFIL System

Inclusion Criteria: * Present with predominant low back pain and symptoms of DDD of the lumbar region of at least 6 months duration * Failure to have their symptoms resolve or reduce following 6 months conservative care (pain medication and/or physical therapy) * Male or female patients aged 22 to 80 years, inclusive * Presence of DDD on magnetic resonance imaging (MRI) scan with global disc degeneration. Modified Pfirrmann grades 5 to 8 as characterized by MRI * The presence of one or two symptomatic discs exhibiting degeneration contained within a competent outer annulus as determined by MRI and provocative discography and/or anaesthetic discography at L1-S1 * Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation * Signed an informed subject consent form in a language in which they are fluent Exclusion Criteria: * History of or current systemic or local infection * Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography * Presence of disc herniation that accounts for the majority of the patient's symptoms * Subjects with Modic type 3 changes * Subjects with trans-endplate disc herniations or Schmorl's nodes * Neurogenic claudication due to spinal stenosis * Previous back surgery at the target level of the lumbar spine * Evidence of severe compression of cauda equina * Spinal segmental instability (spondylolysis or spondylolisthesis: Grade \>1), spinal can…