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 < 5 mm)

2. Chronic Lower Back Pain for at least 6 months

3. Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers

4. 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)

5. Failure of supervised therapy and education

6. Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week)

7. Screening Oswestry Disability Index (ODI) score ≥ 30 and < 90 on a 100-point scale

8. No localized and significant pain below beltline (i.e., potential sacroiliac joint pain) without lumbar pain component

9. 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

10. 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

11. Has degenerative disc disease (DDD) as defined by the following:

12. Changes from normal disc morphology of the affected disc as defined by radiographic evaluation

13. Modified Pfirrmann score of 2 to 7 on MRI, may contain a contained protrusion and/or annular tear on MRI

14. Modified Pfirrmann score of 1 must contain a contained protrusion and/or annular tear on MRI

15. Modic Grade I or II changes or no change on MRI

16. Maintained intervertebral disc heights of at least 50% on MRI.

17. 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

18. 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

19. Aged 18 to 60 years

20. Willing and able to provide written informed consent

21. 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 >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 on 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 < 100,000

8. International Normalized Ratio (INR) > 1.5

9. Extreme obesity, as defined by National Institute of Health (NIH) Clinical Guidelines Body Mass Index (BMI >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.) 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 non-steroidal 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 prior stem cell/progenitor cell therapy or other biological intervention to repair a lumbosacral intervertebral disc

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 (e.g., systemic lupus erythematosus)

24. Required chronic immunosuppression

25. Positive hepatitis C virus (HCV) antibody test

26. Positive human immunodeficiency virus (HIV) Ag/Ab Combo test

27. Pregnant or lactating women

28. Women of childbearing potential not protected by a highly-effective method of birth control

29. Clinically significant hematology and chemistry including, but not limited to: a. Total bilirubin level ≥ 1.5 times institutional upper limit of normal (ULN) b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 x ULN c. Absolute neutrophil count (ANC) < 1000/mm3 d. Hemoglobin ≤ 10 g/dL e. Creatinine clearance use calculated clearance (Cockcroft-Gault equation) of ≤ 50 mL/min

30. Any other condition which in the judgment of the Investigator would preclude adequate evaluation of the safety and efficacy of the study drug

31. Inability to comply with the requirements of the study protocol

32. History of using nicotine delivery products (active within 3 months of study treatment prior to informed consent date)

33. Actively on workers compensation or no-fault case for this complaint or any other active case or litigation pertaining to their lumbosacral pain

34. History of drug abuse or documented history of noncompliance with controlled substances

35. History of regular, long term, daily opioid drug use (>30 MME)