A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Intervention: Intradiscal rhGDF-5; Water for injection
Intervention description: The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.; Sterile water for injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early
      lumbar disc degeneration
    

Eligibility criteria:

        Inclusion Criteria:

          1. Persistent low back pain with at least 3 months of non-surgical therapy at one
             suspected symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized
             provocative discography protocol. The required discography protocol will be provided
             by the sponsor. Subjects with multilevel disease must have a provocative discogram
             confirming that only 1 level is symptomatic at least 2 weeks prior to administration.
             Historical provocative discograms may be used for screening purposes, with an expiry
             of 12 calendar months from the date performed. If the study treatment is not performed
             within those 12 calendar months, a new discogram will be required.

          2. Oswestry Disability Index (ODI) for low back pain of 30 or greater

          3. Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale
             (VAS) at Visit 1 Baseline

        Exclusion Criteria:

          1. Persons unable to have a discogram, CT, or MRI

          2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)

          3. Active radicular pain due to anatomical compression such as stenosis or disc
             herniation (radicular pain is defined as pain below the knee)

          4. Extravasation of contrast agent during the discogram, into the epidural space (does
             not include leakage of contrast agent along the needle track or leakage to the outer
             annular ring at the posterior longitudinal ligament vicinity)

          5. Suspected symptomatic facet joints and/or severe facet joint degeneration at the index
             level or adjacent segments