Intradiscal rhGDF-6 for the Treatment of Lumbar Disc Degeneration
CBT005
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
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2026
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
July 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
June 25, 2026
June 1, 2026
2.2 years
June 1, 2026
June 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Visual Analog Scale
From enrollment through to 12 months
EQ5D-5L
From enrollment through to 12 months
Study Arms (2)
Low dose
ACTIVE COMPARATOR2mg dose of Growth differentiation factor 6
High dose
ACTIVE COMPARATOR4mg dose of Growth differentiation factor 6
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spine & Scoliosis Service
Kogarah, New South Wales, 2217, Australia
Related Publications (2)
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.
PMID: 19521550BACKGROUNDMiyazaki 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.
PMID: 29460012BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- In Phase 2, outcome assessor and participant will be masked
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 25, 2026
Study Start
July 4, 2026
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
December 1, 2030
Last Updated
June 25, 2026
Record last verified: 2026-06