Back Pain, Disc Degenerative Disease
Conditions
Keywords
Back Pain
Brief 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
Interventions
Sponsors
Cartago Biotech Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
In Phase 2, outcome assessor and participant will be masked
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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). 2. MRI scans show Pfirrmann disc degeneration grade 2 to 4 or High Intensity Zone (HIZ) signal change with or without Modic endplate changes. 3. Symptoms are a fair bit or a lot bothersome, which require medication or other types of treatments or very disrupting (in response to question\*). 4. Preoperative Oswestry Disability Index (ODI) score greater than or equal to 30% 5. Visual Analog Score for back pain ≥40 mm. 6. Any gender, 18 years of age or older 7. Clinician diagnosed discogenic pain 8. A signed HREC-approved Informed Consent Form 9. Able to meet the protocol follow-up schedule and activities 10. Females of childbearing potential must have a negative urine/serum pregnancy test at screening (Baseline Visit) and on the day of administration prior to injection \*Question defined in full protocol
Exclusion criteria
1. People unable to have an MRI 2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy) 3. Active radicular pain due to anatomical compression such as stenosis or disc herniation 4. Symptomatic facet joints and/or severe facet degeneration at the index level or adjacent segments 5. Symptomatic Sacro-iliac joint 6. MRI findings demonstrate any of the following: Suspected disc appears normal or \>50% decrease in disc height or Presence of symptomatic osteophytes 7. 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. 8. Presence of spondylolisthesis (anterolisthesis, retrolisthesis is acceptable) 9. Symptomatic disc degeneration at more than 2 lumbar levels (multi-level disc degeneration based on MRI findings is acceptable with up to two symptomatic level. Only the symptomatic levels will be treated) 10. Evidence of active infection 11. Immunosuppressive therapy within 3 months prior to investigational product administration 12. Either continuous or cumulative use of more than 2 months use in the past 6 months of an oral or systemic steroid. Inhaled steroids are acceptable 13. Tumor in the spine 14. People with any current and previous cancer. An exemption to this is previous BCCs which have been successfully removed. 15. Non-contained herniated nucleus pulposus 16. Any prior intradiscal therapies (chemonucleolysis, IDET, intradiscal steroid injection) at the same level being treated, other than rhGDF-6. 17. Any non-intradiscal steroid injection less than 2 months prior to administration. Does not include isolated joint injections outside the lumbar region. 18. Nerve block injection less than 2 months prior to injection of study medication. 19. Known autoimmune disease 20. Type 1 Insulin-dependent diabetes mellitus (Type II, non-insulin dependent diabetes mellitus is allowed) 21. Pregnant or lactating, or wishes to become pregnant within the first 12 months of the study 22. Involved in pending litigation of the spine (including workers compensation cases) 23. Demonstrates signs of non-organic pain (e.g., Waddell's Signs) 24. Based on clinical history, physical examination and participant presentation, participant has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude participants from providing adequate consent and/or complying with study requirements 25. Prisoner 26. Morbid Obesity, defined as Body Mass Index (BMI) ≥40 27. Life expectancy less than 2 years 28. Any significant psychological disturbance past or present, that could impair the consent process or ability to complete participant self-report questionnaires 29. Any reason not cited above that, in the opinion of the Principal Investigator, would pose a risk to either the participant or to the integrity of the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological Status | From enrollment through to 12 months | Safety will be evaluated by assessing neurologic status and the type, frequency, and severity of adverse events through 12 months. |
| Oswestry Disability Index (ODI) | Enrollment through to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | From enrollment through to 12 months | 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. |
| EQ5D-5L | From enrollment through to 12 months | 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. |
Countries
Australia
Contacts
CONTACTAshish Diwan
CONTACTNeha Chopra
Outcome results
None listed