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

• Status: Not yet recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, saline-controlled, and randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioRestorative Therapies

Criteria

Inclusion Criteria:

1. A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions < 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 and education

5. No significant thigh or leg pain (less than 20 mm on VAS)

6. Baseline of greater than or equal to 40 mm and less than or equal to 80 mm on low back pain visual analog scales (VAS) (average pain in the last week)

7. Baseline Oswestry Disability Index (ODI) score greater than or equal to 30 and less than 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. Leg pain, if present, is 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 in the last 18 months prior to the study screening 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 6 on MRI

3. Modic Grade I or II changes, or no change, on MRI

4. May contain a contained protrusion and/or annular tear on MRI

5. Maintained intervertebral disc heights of at least 50%

6. Discography, if not performed within the last 6 months, 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 to 60 years

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

Exclusion Criteria:

1. Spinal Deformity (Scoliosis >10 degrees, spondylolysis, spondylolisthesis, retrolisthesis)

2. Disc extrusions, sequestered fragments, facet cysts, or greater than mild spinal stenosis, or more severe disc degeneration by MRI

3. Presence of a Grade V annular fissure on discography in a subject for whom provocation discography has been performed, and no intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 7 or greater

4. Any bleeding disorder, intrinsic or extrinsic

5. Required anticoagulation (with either antiplatelet agents or antithrombotics) that cannot be interrupted for harvest and injection procedures

6. Platelet count < 100,000

7. International Normalized Ratio (INR) > 1.5

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

9. Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films (flexion & extension films)

10. Has undergone any previous lumbosacral spine surgery (e.g. discectomy, laminectomy, foraminotomy, fusion, intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation.) or therapeutic percutaneous disc intervention

11. Have any acute or chronic lumbosacral spine fracture

12. Have a history of lumbosacral epidural steroid injections within 1 month prior to study treatment

13. Have received systemic or local nonsteroidal anti-inflammatory drugs (NSAIDS) injections into the index and/or adjacent vertebral levels within 72 hours prior to study treatment

14. Have a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)

15. Active significant non lumbosacral spinal orthopedic pain generators including, not limited to arthritic hip and/or knee, cervical disc disease

16. More widespread and ill-defined myofascial pain

17. Have had treatment with any cellular or biological investigational therapy or device within 6 months of study procedure and/or plans to participate in any other autologous or allogeneic stem cell/progenitor cell therapy trial during the 3-year follow-up period

18. Have been a recipient of prior stem cell/progenitor cell therapy or other biological intervention to repair a lumbosacral intervertebral disc

19. 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

20. Apparent ongoing and poorly controlled psychological or somatic disease that may impact treatment outcomes

21. Social, familial, or geographical hindrances to compliance with the study protocol or the informed consent process.

22. Known autoimmune disease (e.g., systemic lupus erythematosus)

23. Required chronic immunosuppression

24. Positive hepatitis C virus (HCV) antibody test

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

26. Pregnant or lactating women

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

28. Clinically significant hematology and chemistry including, but not limited to:

1. Total bilirubin level greater than or equal to 1.5 times institutional upper limit of normal (ULN)

2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 2 x ULN

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

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

5. Creatinine clearance use calculated clearance (Cockcroft-Gault equation) of less than or equal to 50 mL/min or estimated plasma creatinine clearance of greater than or equal to 50 mL/min

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

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

31. History of smoking (active within 3 months of study treatment)

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

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

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