Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration

Inclusion criteria

• Persistent low back pain, with at least 3 months of non-surgical therapy, at one symptomatic disc or two symptomatic lumbar disc levels (from L2 to S1).
• MRI scans show Pfirrmann disc degeneration grade 2 to 4 or High Intensity Zone (HIZ) signal change with or without Modic endplate changes.
• Symptoms are a fair bit or a lot bothersome, which require medication or other types of treatments or very disrupting (in response to question*).
• Preoperative Oswestry Disability Index (ODI) score greater than or equal to 30%
• Visual Analog Score for back pain ≥40 mm.
• Any gender, 18 years of age or older
• Clinician diagnosed discogenic pain
• A signed HREC-approved Informed Consent Form
• Able to meet the protocol follow-up schedule and activities
• Females of childbearing potential must have a negative urine/serum pregnancy test at screening (Baseline Visit) and on the day of administration prior to injection *Question defined in full protocol

Exclusion criteria

• People unable to have an MRI
• Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
• Active radicular pain due to anatomical compression such as stenosis or disc herniation
• Symptomatic facet joints and/or severe facet degeneration at the index level or adjacent segments
• Symptomatic Sacro-iliac joint
• MRI findings demonstrate any of the following: Suspected disc appears normal or >50% decrease in disc height or Presence of symptomatic osteophytes
• Any prior lumbar spinal surgeries at suspected symptomatic level; prior surgery at the adjacent levels is acceptable including fusion or arthroplasty, provided the said adjacent level is not independently symptomatic.
• Presence of spondylolisthesis (anterolisthesis, retrolisthesis is acceptable)
• Symptomatic disc degeneration at more than 2 lumbar levels (multi-level disc degeneration based on MRI findings is acceptable with up to two symptomatic level. Only the symptomatic levels will be treated)
• Evidence of active infection
• Immunosuppressive therapy within 3 months prior to investigational product administration
• Either continuous or cumulative use of more than 2 months use in the past 6 months of an oral or systemic steroid. Inhaled steroids are acceptable
• Tumor in the spine
• People with any current and previous cancer. An exemption to this is previous BCCs which have been successfully removed.
• Non-contained herniated nucleus pulposus
• Any prior intradiscal therapies (chemonucleolysis, IDET, intradiscal steroid injection) at the same level being treated, other than rhGDF-6.
• Any non-intradiscal steroid injection less than 2 months prior to administration. Does not include isolated joint injections outside the lumbar region.
• Nerve block injection less than 2 months prior to injection of study medication.
• Known autoimmune disease
• Type 1 Insulin-dependent diabetes mellitus (Type II, non-insulin dependent diabetes mellitus is allowed)
• Pregnant or lactating, or wishes to become pregnant within the first 12 months of the study
• Involved in pending litigation of the spine (including workers compensation cases)
• Demonstrates signs of non-organic pain (e.g., Waddell's Signs)
• Based on clinical history, physical examination and participant presentation, participant has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude participants from providing adequate consent and/or complying with study requirements
• Prisoner
• Morbid Obesity, defined as Body Mass Index (BMI) ≥40
• Life expectancy less than 2 years
• Any significant psychological disturbance past or present, that could impair the consent process or ability to complete participant self-report questionnaires
• Any reason not cited above that, in the opinion of the Principal Investigator, would pose a risk to either the participant or to the integrity of the clinical trial