Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCartago Biotech Pty Ltd
About this trial
The goal of this clinical trial is to find out if a new medicine can help people who have long-lasting back pain caused by damaged spinal discs. The study will also check if the medicine is safe to use.
The main questions this study aims to answer are:
Is the medicine safe, and what amount works best? Can it reduce long-term back pain?
Researchers will test a medicine called CBT005, which contains a healing protein, by injecting it into the spinal discs. They will watch closely to see how people respond to the treatment.
Participants will:
Receive one study injection into the spinal disc Visit the clinic in person during the first 12 months for checkups Receive phone calls at 24 and 36 months to see how they are doing Still be able to get other pain treatments in the future, including surgery, if needed
Eligibility criteria
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- High Dose
- Low Dose
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov