Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration (NCT07668466) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration
Australia60 participantsStarted 2026-07-04
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)