Disc Degenerative DiseasePhase 1/2CBT005NCT07668466
Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration
A Phase 1/2 study testing High Dose and Low Dose in people with Disc Degenerative Disease and Back Pain, run by Cartago Biotech Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disc Degenerative Disease, Back Pain
- What is being tested?
- High Dose and Low Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Jul 2026to 1 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Clinician diagnosed discogenic pain
- A signed HREC-approved Informed Consent Form
- Able to meet the protocol follow-up schedule and activities
- 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
Who cannot join
- 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
- 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
Show all 29Show fewer
- 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)
- 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)
- Evidence of active infection
- Immunosuppressive therapy within 3 months prior to investigational product administration
- 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
- Tumor in the spine
- People with any current and previous cancer. An exemption to this is previous BCCs which have been successfully removed.
- Non-contained herniated nucleus pulposus
- Any prior intradiscal therapies (chemonucleolysis, IDET, intradiscal steroid injection) at the same level being treated, other than rhGDF-6.
- Any non-intradiscal steroid injection less than 2 months prior to administration. Does not include isolated joint injections outside the lumbar region.
- Nerve block injection less than 2 months prior to injection of study medication.
- Known autoimmune disease
- Type 1 Insulin-dependent diabetes mellitus (Type II, non-insulin dependent diabetes mellitus is allowed)
- Pregnant or lactating, or wishes to become pregnant within the first 12 months of the study
- Involved in pending litigation of the spine (including workers compensation cases)
- Demonstrates signs of non-organic pain (e.g., Waddell's Signs)
- 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
- Prisoner
- Morbid Obesity, defined as Body Mass Index (BMI) ≥40
- Life expectancy less than 2 years
- Any significant psychological disturbance past or present, that could impair the consent process or ability to complete participant self-report questionnaires
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Spine & Scoliosis Service
Kogarah, New South Wales, 2217
Nerida Clinical Coordinator, Registered Nurse, 0285667166, info@spine-service.org
About this study
Official title: A Phase I/II, Open-label, Single Administration Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration
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:
Read more
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
- Conditions
- Disc Degenerative Disease, Back Pain
- Being tested
- High Dose, Low Dose
- Keywords
- Back Pain
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High DoseBiological
High Dose: 4 mg dose of Growth differentiation factor 6
Low DoseBiological
Low dose: 2mg dose of Growth differentiation factor 6
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Active comparator | 2mg dose of Growth differentiation factor 6 Receives: Biological: Low Dose |
| High dose | Active comparator | 4mg dose of Growth differentiation factor 6 Receives: Biological: High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Status
Safety will be evaluated by assessing neurologic status and the type, frequency, and severity of adverse events through 12 months.
Measured: 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.
Measured: Enrollment through to 12 months
Secondary outcomes (2)
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.
Measured: From enrollment through to 12 months
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.
Measured: From enrollment through to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start4 Jul 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disc Degenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cartago Biotech Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668466
- Sponsor's protocol ID
- 001-CBT-005 Intradiscal rhGDF6
- Acronym
- CBT005
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19521550Miyazaki 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.
PubMed 29460012
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label, Single Administration Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration
- ClinicalTrials.gov ID
- NCT07668466
- Acronym / sponsor ID
- CBT005 / 001-CBT-005 Intradiscal rhGDF6
- Conditions
- Disc Degenerative Disease, Back Pain
- Keywords
- Back Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cartago Biotech Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Active comparator | Biological: Low Dose2mg dose of Growth differentiation factor 6 |
| High dose | Active comparator | Biological: High Dose4mg dose of Growth differentiation factor 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (29 listed)
- 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
- Symptomatic Sacro-iliac joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High DoseHigh Dose: 4 mg dose of Growth differentiation factor 6 | Biological | High dose |
| Low DoseLow dose: 2mg dose of Growth differentiation factor 6 | Biological | Low dose |
Primary outcome
Neurological Status
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Visual Analog Scale
Time frame: From enrollment through to 12 months
EQ5D-5L
Time frame: From enrollment through to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 19521550Wei 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.
- Background: PubMed 29460012Miyazaki 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing High Dose and Low Dose in people with Disc Degenerative Disease and Back Pain, run by Cartago Biotech Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashish Diwan (+61 409257177, ashish@cartago-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological Status (time frame: From enrollment through to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.