Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Active Comparator | 2mg dose of Growth differentiation factor 6 |
|
| High dose | Active Comparator | 4mg dose of Growth differentiation factor 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose | Biological | High Dose: 4 mg dose of Growth differentiation factor 6 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological Status | Safety will be evaluated by assessing neurologic status and the type, frequency, and severity of adverse events through 12 months. | From enrollment through to 12 months |
| 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. | Enrollment through to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment through to 12 months |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashish Diwan | Contact | +61 409257177 | ashish@cartago-biotech.com | |
| Neha Chopra | Contact | +61 478943074 | neha@cartago-biotech.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine & Scoliosis Service | Kogarah | New South Wales | 2217 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19521550 | Background | Wei A, Williams LA, Bhargav D, Shen B, Kishen T, Duffy N, Diwan AD. BMP13 prevents the effects of annular injury in an ovine model. Int J Biol Sci. 2009 Jun 3;5(5):388-96. doi: 10.7150/ijbs.5.388. | |
| 29460012 | Background | Miyazaki S, Diwan AD, Kato K, Cheng K, Bae WC, Sun Y, Yamada J, Muehleman C, Lenz ME, Inoue N, Sah RL, Kawakami M, Masuda K. ISSLS PRIZE IN BASIC SCIENCE 2018: Growth differentiation factor-6 attenuated pro-inflammatory molecular changes in the rabbit anular-puncture model and degenerated disc-induced pain generation in the rat xenograft radiculopathy model. Eur Spine J. 2018 Apr;27(4):739-751. doi: 10.1007/s00586-018-5488-1. Epub 2018 Feb 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
Not provided
Not provided
Not provided
In Phase 2, outcome assessor and participant will be masked
Not provided
| Low Dose |
| Biological |
Low dose: 2mg dose of Growth differentiation factor 6 |
|
| 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. | From enrollment through to 12 months |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |