A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
Trial Parameters
Brief Summary
This is a double-blind, controlled, 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. Chronic lumbar disc disease is defined as back and/or radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means.
Eligibility Criteria
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) 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 (such as physical therapy) 5. Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week) 6. Screening Oswestry Disability Index (ODI) score ≥ 30 and \< 90 on a 100-point scale