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)

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 orall of the following: rest, anti-inflammatory medication, analgesics,narcotics, epidural injections or selective nerve root injections at the targetlevel, facet joint injections, muscle relaxers, massage, acupuncture,chiropractic care)

5. Failure of supervised therapy (such as physical therapy)

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-pointscale

8. No localized and significant pain below beltline (i.e., potential sacroiliacjoint 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 spinalnerve by compressive forces

10. Diagnostic medial branch block or facet joint injection (bilateral unless thesymptoms are purely unilateral in nature) in the last 12 months prior to theinformed 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 byradiographic evaluation

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

14. Modified Pfirrmann score of 1 must contain a contained protrusion and/orannular 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 informedconsent date, has to be performed if more than one degenerative disc isidentified by MRI, and the symptomatic disc cannot be otherwise reasonablydetermined

18. If more than one degenerative disc is identified by MRI, no disc shalldemonstrate greater degenerative change than the symptomatic disc or contain aprotrusion greater than 5mm

19. Aged ≥18 years of age at the time of consent

20. Willing and able to provide written informed consent

21. No evidence of contraindications to the procedure such as pregnancy, activeinfection, 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 spinalstenosis on MRI.

3. Presence of a Grade V annular fissure observed within the index disc level duringdiscography in a subject for whom provocation discography has been performed

4. Intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 8 orgreater

5. Any bleeding disorder, intrinsic or extrinsic

6. Required anticoagulation (with either antiplatelet agents or antithrombotics) thatcannot 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 greaterthan or equal to 40)

10. Clinically relevant instability on flexion-extension as determined by theinvestigator by overlaying films (flexion & extension films)

11. Has undergone any previous lumbosacral spine surgery (e.g. discectomy, laminectomy,foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequencythermocoagulation.), ablation of lumbar basiverterbral nerve or therapeuticpercutaneous disc intervention

12. Have any acute or chronic lumbosacral spine fracture

13. Have a history of lumbosacral epidural steroid injections within 1 month prior toinformed 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 dimethylsulfoxide (DMSO)

16. Active significant non lumbosacral spinal orthopedic pain generators including, notlimited 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 devicewithin 6 months of informed consent date and/or plans to participate in any otherautologous or allogeneic stem cell/progenitor cell therapy trial during the 2 yearfollow-up period

19. Have been a recipient of any lumbosacral intervertebral disc injection fortherapeutic purposes

20. Are transient or has been treated in the last 6 months before enrollment for alcoholand/or drug abuse in an inpatient substance abuse program

21. Apparent ongoing and poorly controlled psychological or somatic disease that mayimpact treatment outcomes

22. Social, familial, or geographical hindrances to compliance with the study protocolor the informed consent process

23. Known autoimmune disease with primary impact on the musculoskeletal and/orneurological 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 immunodeficiency virus (HIV) Antigen/Antibody (Ag/Ab) Combo test

27. Pregnant or lactating women

28. Women of childbearing potential not protected by a highly effective method of birthcontrol. Highly effective methods of contraception [defined as those, alone or incombination, that result in a low (<1%) failure rate] include, but are not limitedto, combined (estrogen- and progestogen-containing) hormonal contraceptionassociated with inhibition of ovulation (either oral, intravaginal, transdermal orinjectable), progestogen-only hormonal contraception associated with inhibition ofovulation (either oral, injectable or implantable), intrauterine device,intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomizedpartner, sexual abstinence, or a double-barrier method (i.e., male condom combinedwith diaphragm with spermicide). The investigator is responsible for review ofmedical history, contraception history, menstrual history and recent sexual activityto decrease the risk of including a woman with an undetected early pregnancy.Additionally, the investigator is responsible for determining if, in theinvestigator's judgment, a woman's planned contraceptive method (including anassessment of her reliability for consistent use of this method) meets the protocolrequirement of "highly effective."

29. Hematology and chemistry values including, but not limited to:

30. Total bilirubin level 1.5 times institutional upper limit of normal (ULN)

31. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 x ULN

32. Absolute neutrophil count (ANC) < 1000/mm3

33. Hemoglobin less than or equal to 10 g/dL

34. Creatinine clearance use calculated clearance (Cockcroft-Gault equation) ofless than or equal to 50 mL/min

35. Other labs deemed clinically significant which, in the opinion of theinvestigator, might influence the subject's health or safety during the trial.

36. Have any other active medical conditions, medical or psychiatric illness which, inthe opinion of the Investigator, would preclude adequate evaluation of the safetyand efficacy of the study or put the participant at risk

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

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

39. History of drug or alcohol abuse or documented history of noncompliance withcontrolled substances that, in the investigator's opinion, could interfere withadequate evaluation of the study drug's safety or efficacy or otherwise make thesubject unsuitable for the study.

40. History of regular, long term, daily opioid drug use (greater than or equal to 30MME)