Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

Inclusion Criteria:

1. 18 years of age or older

2. Back pain greater than 'worst leg pain' as measured by the NRS

3. Diagnosed with one or two contiguous level(s) lumbar (L1-S1) disc degeneration ofPfirrmann Grade 3 and/or 4 determined by MRI analyzed by the independent radiologiccentral lab

4. Have chronic low back pain and related disability for at least 6 months with atleast 3 months of prior conservative treatment

5. Baseline ODI score ≥ 40/100

6. Baseline NRS ≥ 4 points (Back)

7. Willing and able to provide Informed Consent for study participation

8. Willing and able to comply with this protocol and be available for the entireduration of the study, including ability to access the internet

9. Must practice effective contraception during the first 3 months of follow-up (femaleof childbearing potential and male subjects):

10. Abstinence or,

11. Surgical Sterilization or,

12. Oral Contraceptives or,

13. Barrier Methods (Condoms, IUD's).

14. Patient must verify that:

15. In the case of females, the patient is post-menopausal or is surgically sterileor,

16. In the case of males, the patient is surgically sterile or,

17. The patient (male or female) confirms that they are at a point in their lifewhere they are beyond consideration of having children.

Exclusion Criteria:

To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows.

1. Prior epidural, sacroiliac joint, and facet injections, or facet RFA (radiofrequencyablations) at any lumbosacral level within the past 4 weeks (e.g., transforaminal,interlaminar, caudal)

2. Prior interventional procedures of other types at any lumbosacral level at any time (e.g., intradiscal injection, basivertebral nerve ablation, biacuplasty, spinal cordstimulator, others)

3. Prior spine surgery at any lumbosacral level at any time (e.g., discectomy,decompression, instrumentation, fusion, fracture treatment, others)

4. Prior fracture at any lumbar level

5. Significant neurologic symptoms:

6. Grade 3/5 or lower strength in any lumbar myotome

7. Sensory deficit in a clearly radicular or sensory dermatome

8. MRI evidence of disc height loss > 2/3 of adjacent disc at any level to be injected,determined by the independent radiologic central lab

9. MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to beinjected, determined by the independent radiologic central lab

10. MRI evidence of disc herniation with neural compression at any level, determined bythe independent radiologic central lab

11. MRI evidence of significant stenosis of the central canal at any level, determinedby the independent radiologic central lab

12. MRI evidence of foraminal stenosis with neural compression at any level, determinedby the independent radiologic central lab

13. MRI evidence of moderate-to-severe facet arthrosis with edema at any level,determined by the independent radiologic central lab

14. Spondylolisthesis (antero or retrolisthesis) > 25% at any level, determined by theindependent radiologic central lab

15. Lumbar coronal deformity, determined by the independent radiologic central lab: a. L1-S1 regional deformity > 25 degrees

16. Spondylolysis at any level

17. Lumbar inflammatory spondylitis

18. Recent history (previous six months) of chemical or alcohol dependence

19. Chronic narcotic use for more than defined as a daily dose of greater than 40Morphine Equivalent Units (MEUs)

20. Depression or Somatization defined through the Distress and Risk Assessment Method (DRAM) scoring with Zung score > 33 or Zung > 17 and the Modified Somatic PerceptionQuestionnaire (MSPQ) score > 12

21. Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)

22. A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 470millisecond (msec)

23. Active systemic infection

24. Infection at the site of procedure pre-operatively

25. Cauda equina syndrome or neurogenic bowel/bladder dysfunction

26. Any terminal, systemic, or autoimmune disease including fibromyalgia, which may, inthe opinion of the Principal Investigator compromise a subject's ability to complywith study procedures, and/or confound data

27. Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget'sdisease)

28. Any disease, condition or surgery which might impair healing, such as:

29. Active malignancy

30. History of metastatic malignancy

31. Currently experiencing an episode of major mental illness (psychosis, majoraffective disorder, or schizophrenia), or manifesting physical symptoms without adiagnosable medical condition to account for the symptoms, which may indicatesymptoms of psychological rather than physical origin

32. Any planned surgical procedure within the subject participation period (screeningthrough the 12 Month Visit)

33. Any clinically relevant laboratory result on the screening visit Chem-12,hematology, or coagulation panels

34. Pregnancy at the time of screening, randomization, or planning to become pregnantduring the first 3 months of follow-up

35. Currently a prisoner

36. Participation in any other investigational drug, biologic, or medical device studywithin the last 6 months prior to study procedure

37. Receiving Work Compensation benefits or engaged in personal spinal injurymedical/legal litigation

38. Patient cannot be currently using the prohibited medications listed in the protocol