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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
High Dose
Biological/VaccineHigh Dose: 4 mg dose of Growth differentiation factor 6
Low Dose
Biological/VaccineLow dose: 2mg dose of Growth differentiation factor 6
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Low doseActive comparator 1 intervention
Group B: High doseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neurological Status
Safety will be evaluated by assessing neurologic status and the type, frequency, and severity of adverse events through 12 months.
Time frame
From enrollment through to 12 months2
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) assesses functional limitations in activities of daily living related to back pain. The ODI consists of 10 questions, each addressing a specific aspect of daily living affected by back pain, such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual activity, social life, and travel. Each question has six statements that correlate to a score of 0 to 5. The patient chooses the statement that best describes their current condition, with higher scores indicating greater disability. The total score is calculated by summing the individual question scores and then dividing by the total possible score (which is 50) and multiplying by 100 to get a percentage disability.
Time frame
Enrollment through to 12 monthsSecondary outcomes
1
Visual Analog Scale
VAS will be meausred on a millimeter (mm) scale. It is a 100-mm continuous line used to measure subjective experiences like pain, fatigue, or quality of life. Scores will be calculated by measuring the distance in millimeters from the left anchor (usually "no symptom") to the patient's mark.
Time frame
From enrollment through to 12 months2
EQ5D-5L
The EQ-5D-5L is a widely used generic health-related quality of life instrument developed in the 1980s by the EuroQol Group to assess and compare health status across different diseases and populations. An EQ-5D 5L health state is converted into a utility score by subtracting the weighted values assigned to the selected levels in each of the five health dimensions from a baseline of 1. The weights assigned to each level within the health dimensions reflect the relative impact of those health problems on overall quality of life.
Time frame
From enrollment through to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: