A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)

Subject Inclusion Criteria: A subject is eligible for inclusion if all the following criteria are met: 1. A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions less than or equal to 5 mm) 1. Chronic Lower Back Pain for at least 6 months 2. Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers 3. Failure of at least 6 months of conservative back pain care (can include any or all of the following: rest, anti-inflammatory medication, analgesics, narcotics, epidural injections or selective nerve root injections at the target level, facet joint injections, muscle relaxers, massage, acupuncture, chiropractic care) 4. Failure of supervised therapy (such as physical therapy) 5. Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week) 6. Screening Oswestry Disability Index (ODI) score ≥ 30 and \< 90 on a 100-point scale 7. No localized and significant pain below beltline (i.e., potential sacroiliac joint pain) without lumbar pain component 8. Thigh or Leg pain, if present, is non prevailing and of nonradicular origin, i.e., not due to stimulation of nerve roots or dorsal root ganglion of a spinal nerve by compressive forces 9. Diagnostic medial branch block or facet joint injection (bilateral unless the symptoms are purely unilateral in nature) in the last 12 months prior to the informed consent date indicates no prevailing facet joint involvement 2. Has degenerative disc disease (DDD) as defined by the following: 1. Changes from normal disc morphology of the affected disc as defined by radiographic evaluation 2. Modified Pfirrmann score of 2 to 7 on MRI, may contain a contained protrusion and/or annular tear on MRI 3. Modified Pfirrmann score of 1 must contain a contained protrusion and/or annular tear on MRI 4. Modic Grade I or II changes or no change on MRI 5. Maintained intervertebral disc heights of at least 50% on MRI. 6. Discography, if not performed within the last 6 months prior to informed consent date, has to be performed if more than one degenerative disc is identified by MRI, and the symptomatic disc cannot be otherwise reasonably determined 7. If more than one degenerative disc is identified by MRI, no disc shall demonstrate greater degenerative change than the symptomatic disc or contain a protrusion greater than 5mm 3. Aged ≥18 years of age at the time of consent 4. Willing and able to provide written informed consent 5. No evidence of contraindications to the procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer Subject Exclusion Criteria: A subject is not eligible to participate if any of the following criteria are met: 1. Spinal Deformity (Scoliosis greater than or equal to 20 degrees, spondylolysis, clinically or radiographically significant retrolisthesis or spondylolisthesis) detected on MRI or plain film radiographic assessment 2. Disc extrusions, sequestered fragments, facet cysts, or greater than moderate spinal stenosis on MRI. 3. Presence of a Grade V annular fissure observed within the index disc level during discography in a subject for whom provocation discography has been performed 4. Intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 8 or greater 5. Any bleeding disorder, intrinsic or extrinsic 6. Required anticoagulation (with either antiplatelet agents or antithrombotics) that cannot be interrupted for harvest and injection procedures 7. Platelet count less than or equal to 100,000 8. International Normalized Ratio (INR) greater than or equal to 1.5 9. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI greater than or equal to 40) 10. Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films (flexion \& extension films) 11. Has undergone any previous lumbosacral spine surgery (e.g. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation.), ablation of lumbar basiverterbral nerve or therapeutic percutaneous disc intervention 12. Have any acute or chronic lumbosacral spine fracture 13. Have a history of lumbosacral epidural steroid injections within 1 month prior to informed consent date. 14. Planned/expected use of systemic nonsteroidal anti-inflammatory drugs (NSAIDs) within 72 hours prior to study treatment. 15. Have a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO) 16. Active significant non lumbosacral spinal orthopedic pain generators including, not limited to arthritic hip and/or knee, cervical disc disease 17. More widespread and ill-defined myofascial pain 18. Have had treatment with any cellular or biological investigational therapy or device within 6 months of informed consent date and/or plans to participate in any other autologous or allogeneic stem cell/progenitor cell therapy trial during the 2 year follow-up period 19. Have been a recipient of any lumbosacral intervertebral disc injection for therapeutic purposes 20. 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 21. Apparent ongoing and poorly controlled psychological or somatic disease that may impact treatment outcomes 22. Social, familial, or geographical hindrances to compliance with the study protocol or the informed consent process 23. Known autoimmune disease with primary impact on the musculoskeletal and/or neurological systems (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, myasthenia gravis, polymyositis/dermatomyositis, Guillain-Barre syndrome, autoimmune vasculitis) 24. Required chronic immunosuppression 25. Positive hepatitis C virus (HCV) antibody test 26. Positive human im