A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
ConditionLumbar Disc Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioRestorative Therapies
About this trial
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
Qualifiers
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)
Chronic Lower Back Pain for at least 6 months
Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers
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)
Disqualifiers
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
Disc extrusions, sequestered fragments, facet cysts, or greater than moderate spinal stenosis on MRI.
Presence of a Grade V annular fissure observed within the index disc level during discography in a subject for whom provocation discography has been performed
Intervertebral disc with radiographic evidence of Modified Pfirrmann Grade 8 or greater
Trial design
Treatments tested in this trial
- BRTX-100
- Saline
Treatment groups
99 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov