Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain

Inclusion Criteria: * Able to provide an English written Informed Consent * Age 18 to 60 years inclusive * Male or female * Body mass index \<35 * Pfirrmann Grade \[3-6\] * Radiographic confirmation by MRI/X-ray of: 1. translational instability defined as ≤5 mm, or 2. angular instability defined as ≤5° * Back pain (with or without radicular leg pain) measured by: 1. ODI of at least 40%, and 2. VASPI of at least 40mm * Pathologic level between L1 and S1 * 1 or 2 vertebral level involvement that has been evaluated for at least 6 months and treated with conservative care * Symptomatic back pain attributable to intervertebral disc for a minimum of 6 months * No previous surgical treatment at the disc level(s) being considered * Psychosocially, mentally and physically able to fully comply with this protocol, and follow-up schedule * Ability to undergo allograft transplantation * Life expectancy \>2 years * No contraindications to MRI * No history of malignancy (basal cell carcinoma) or chronic infectious disease (e.g. HIV, Hepatitis) * Agree to use appropriate contraception; not planning on becoming pregnant for 24 months after treatment * Patient disc for transplant confirmed by inter-discal pressure measurement, or disc-imaging study. * No signs or symptoms of infection * No chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs prior to treatment Exclusion Criteria: * Seropositive or seronegative spondyloarthropathy * Type III Modic changes * Prior surgeries of segments between L1 and S1 * Chemonucleolysis or percutaneous laserectomy of the affected disc prior to the study * Chronic facet syndrome * Stenosis of the spinal canal that is moderate to severe or more in degree * Spondylodiscitis * Spondylolisthesis (lysis and degenerative) * Severe motor deficit or cauda equina disorder based on investigator determination * Congenital abnormalities of the spinal nerves * Pelvic and inguinal angiopathy * Neurogenic inguinal syndrome * Syringomyelia * Diastematomyelia * Traumatic neurological disorders * Diseases of the kidney (nephritis, pyelonephritis) * Other severe diseases of any other major body system as judged by the investigator * Regular intake of systemic steroids * Malignant diseases of any solid organ or any hematologic malignancy during the previous 5 years * Patients who have participated in a clinical trial within the last month prior to inclusion * Moderate to severe or greater lumbar stenosis of both transplantation endplates and adjacent levels